StructureDefinition-DeviceModel.xml
   1 <?xml version="1.0" encoding="utf-8"?>
   2 <StructureDefinition xmlns="http://hl7.org/fhir">
   3   <id value="DeviceModel" />
   4   <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
   5     <valueCode value="oo" />
   6   </extension>
   7   <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
   8     <valueInteger value="2">
   9       <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
  10         <valueCanonical value="http://hl7.org/fhir/uv/order-catalog/ImplementationGuide/ig-uv-order-catalog" />
  11       </extension>
  12     </valueInteger>
  13   </extension>
  14   <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
  15     <valueCode value="trial-use">
  16       <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
  17         <valueCanonical value="http://hl7.org/fhir/uv/order-catalog/ImplementationGuide/ig-uv-order-catalog" />
  18       </extension>
  19     </valueCode>
  20   </extension>
  21   <url value="http://hl7.org/fhir/uv/order-catalog/StructureDefinition/DeviceModel" />
  22   <identifier>
  23     <system value="urn:ietf:rfc:3986" />
  24     <value value="urn:oid:2.16.840.1.113883.4.642.40.999.42.2" />
  25   </identifier>
  26   <version value="1.0.0-ballot" />
  27   <name value="DeviceModel" />
  28   <title value="Device Model" />
  29   <status value="draft" />
  30   <date value="2022-02-20T18:06:45.0000000+01:00" />
  31   <publisher value="HL7 International / Orders and Observations" />
  32   <contact>
  33     <telecom>
  34       <system value="url" />
  35       <value value="http://www.hl7.org/Special/committees/orders" />
  36     </telecom>
  37   </contact>
  38   <description value="This profile constrains the base resource DeviceDefinition to represent a model of device in a catalog of medical devices" />
  39   <jurisdiction>
  40     <coding>
  41       <system value="http://unstats.un.org/unsd/methods/m49/m49.htm" />
  42       <code value="001" />
  43     </coding>
  44   </jurisdiction>
  45   <fhirVersion value="5.0.0" />
  46   <mapping>
  47     <identity value="devicedefinition-to-eudamed" />
  48     <uri value="https://ec.europa.eu/tools/eudamed" />
  49     <name value="Europe Union EUDAMED" />
  50     <comment value="maps DeviceDefinition elements to EUDAMED UDI data dictionary field IDs|labels" />
  51   </mapping>
  52   <mapping>
  53     <identity value="devicedefinition-to-gudid" />
  54     <uri value="https://accessgudid.nlm.nih.gov/" />
  55     <name value="US GUDID" />
  56     <comment value="maps DeviceDefinition elements to AccessGUDID section titles and field labels" />
  57   </mapping>
  58   <mapping>
  59     <identity value="w5" />
  60     <uri value="http://hl7.org/fhir/fivews" />
  61     <name value="FiveWs Pattern Mapping" />
  62   </mapping>
  63   <mapping>
  64     <identity value="rim" />
  65     <uri value="http://hl7.org/v3" />
  66     <name value="RIM Mapping" />
  67   </mapping>
  68   <kind value="resource" />
  69   <abstract value="false" />
  70   <type value="DeviceDefinition" />
  71   <baseDefinition value="http://hl7.org/fhir/StructureDefinition/DeviceDefinition" />
  72   <derivation value="constraint" />
  73   <snapshot>
  74     <extension url="http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version">
  75       <valueString value="5.0.0" />
  76     </extension>
  77     <element id="DeviceDefinition">
  78       <path value="DeviceDefinition" />
  79       <short value="An instance of a medical-related component of a medical device" />
  80       <definition value="The characteristics, operational status and capabilities of a medical-related component of a medical device." />
  81       <comment value="For the initial scope, this DeviceDefinition resource is only applicable to describe a single node in the containment tree that is produced by the context scanner in any medical device that implements or derives from the ISO/IEEE 11073 standard and that does not represent a metric. Examples for such a node are MDS, VMD, or Channel." />
  82       <min value="0" />
  83       <max value="*" />
  84       <base>
  85         <path value="DeviceDefinition" />
  86         <min value="0" />
  87         <max value="*" />
  88       </base>
  89       <constraint>
  90         <key value="dom-2" />
  91         <severity value="error" />
  92         <human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources" />
  93         <expression value="contained.contained.empty()" />
  94         <source value="http://hl7.org/fhir/StructureDefinition/DomainResource" />
  95       </constraint>
  96       <constraint>
  97         <key value="dom-3" />
  98         <severity value="error" />
  99         <human value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource" />
 100         <expression value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()" />
 101         <source value="http://hl7.org/fhir/StructureDefinition/DomainResource" />
 102       </constraint>
 103       <constraint>
 104         <key value="dom-4" />
 105         <severity value="error" />
 106         <human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated" />
 107         <expression value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()" />
 108         <source value="http://hl7.org/fhir/StructureDefinition/DomainResource" />
 109       </constraint>
 110       <constraint>
 111         <key value="dom-5" />
 112         <severity value="error" />
 113         <human value="If a resource is contained in another resource, it SHALL NOT have a security label" />
 114         <expression value="contained.meta.security.empty()" />
 115         <source value="http://hl7.org/fhir/StructureDefinition/DomainResource" />
 116       </constraint>
 117       <constraint>
 118         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice">
 119           <valueBoolean value="true" />
 120         </extension>
 121         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
 122           <valueMarkdown value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time." />
 123         </extension>
 124         <key value="dom-6" />
 125         <severity value="warning" />
 126         <human value="A resource should have narrative for robust management" />
 127         <expression value="text.`div`.exists()" />
 128         <source value="http://hl7.org/fhir/StructureDefinition/DomainResource" />
 129       </constraint>
 130       <mustSupport value="false" />
 131       <isModifier value="false" />
 132       <isSummary value="false" />
 133       <mapping>
 134         <identity value="devicedefinition-to-eudamed" />
 135         <map value="EUDAMED data dictionary field IDs/labels" />
 136       </mapping>
 137       <mapping>
 138         <identity value="devicedefinition-to-gudid" />
 139         <map value="AccessGUDID section titles and field labels" />
 140       </mapping>
 141       <mapping>
 142         <identity value="rim" />
 143         <map value="Entity, Role, or Act" />
 144       </mapping>
 145       <mapping>
 146         <identity value="w5" />
 147         <map value="administrative.device" />
 148       </mapping>
 149     </element>
 150     <element id="DeviceDefinition.id">
 151       <path value="DeviceDefinition.id" />
 152       <short value="Logical id of this artifact" />
 153       <definition value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes." />
 154       <comment value="Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case." />
 155       <min value="0" />
 156       <max value="1" />
 157       <base>
 158         <path value="Resource.id" />
 159         <min value="0" />
 160         <max value="1" />
 161       </base>
 162       <type>
 163         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
 164           <valueUrl value="id" />
 165         </extension>
 166         <code value="http://hl7.org/fhirpath/System.String" />
 167       </type>
 168       <mustSupport value="false" />
 169       <isModifier value="false" />
 170       <isSummary value="true" />
 171     </element>
 172     <element id="DeviceDefinition.meta">
 173       <path value="DeviceDefinition.meta" />
 174       <short value="Metadata about the resource" />
 175       <definition value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource." />
 176       <min value="0" />
 177       <max value="1" />
 178       <base>
 179         <path value="Resource.meta" />
 180         <min value="0" />
 181         <max value="1" />
 182       </base>
 183       <type>
 184         <code value="Meta" />
 185       </type>
 186       <constraint>
 187         <key value="ele-1" />
 188         <severity value="error" />
 189         <human value="All FHIR elements must have a @value or children" />
 190         <expression value="hasValue() or (children().count() > id.count())" />
 191         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 192       </constraint>
 193       <mustSupport value="false" />
 194       <isModifier value="false" />
 195       <isSummary value="true" />
 196     </element>
 197     <element id="DeviceDefinition.implicitRules">
 198       <path value="DeviceDefinition.implicitRules" />
 199       <short value="A set of rules under which this content was created" />
 200       <definition value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc." />
 201       <comment value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc." />
 202       <min value="0" />
 203       <max value="1" />
 204       <base>
 205         <path value="Resource.implicitRules" />
 206         <min value="0" />
 207         <max value="1" />
 208       </base>
 209       <type>
 210         <code value="uri" />
 211       </type>
 212       <constraint>
 213         <key value="ele-1" />
 214         <severity value="error" />
 215         <human value="All FHIR elements must have a @value or children" />
 216         <expression value="hasValue() or (children().count() > id.count())" />
 217         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 218       </constraint>
 219       <mustSupport value="false" />
 220       <isModifier value="true" />
 221       <isModifierReason value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation" />
 222       <isSummary value="true" />
 223     </element>
 224     <element id="DeviceDefinition.language">
 225       <path value="DeviceDefinition.language" />
 226       <short value="Language of the resource content" />
 227       <definition value="The base language in which the resource is written." />
 228       <comment value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies  to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)." />
 229       <min value="0" />
 230       <max value="1" />
 231       <base>
 232         <path value="Resource.language" />
 233         <min value="0" />
 234         <max value="1" />
 235       </base>
 236       <type>
 237         <code value="code" />
 238       </type>
 239       <constraint>
 240         <key value="ele-1" />
 241         <severity value="error" />
 242         <human value="All FHIR elements must have a @value or children" />
 243         <expression value="hasValue() or (children().count() > id.count())" />
 244         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 245       </constraint>
 246       <mustSupport value="false" />
 247       <isModifier value="false" />
 248       <isSummary value="false" />
 249       <binding>
 250         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
 251           <valueString value="Language" />
 252         </extension>
 253         <strength value="required" />
 254         <description value="IETF language tag for a human language" />
 255         <valueSet value="http://hl7.org/fhir/ValueSet/all-languages|5.0.0" />
 256       </binding>
 257     </element>
 258     <element id="DeviceDefinition.text">
 259       <path value="DeviceDefinition.text" />
 260       <short value="Text summary of the resource, for human interpretation" />
 261       <definition value="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety." />
 262       <comment value="Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied).  This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later." />
 263       <alias value="narrative" />
 264       <alias value="html" />
 265       <alias value="xhtml" />
 266       <alias value="display" />
 267       <min value="0" />
 268       <max value="1" />
 269       <base>
 270         <path value="DomainResource.text" />
 271         <min value="0" />
 272         <max value="1" />
 273       </base>
 274       <type>
 275         <code value="Narrative" />
 276       </type>
 277       <condition value="dom-6" />
 278       <constraint>
 279         <key value="ele-1" />
 280         <severity value="error" />
 281         <human value="All FHIR elements must have a @value or children" />
 282         <expression value="hasValue() or (children().count() > id.count())" />
 283         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 284       </constraint>
 285       <mustSupport value="false" />
 286       <isModifier value="false" />
 287       <isSummary value="false" />
 288       <mapping>
 289         <identity value="rim" />
 290         <map value="Act.text?" />
 291       </mapping>
 292     </element>
 293     <element id="DeviceDefinition.contained">
 294       <path value="DeviceDefinition.contained" />
 295       <short value="Contained, inline Resources" />
 296       <definition value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning." />
 297       <comment value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels." />
 298       <alias value="inline resources" />
 299       <alias value="anonymous resources" />
 300       <alias value="contained resources" />
 301       <min value="0" />
 302       <max value="*" />
 303       <base>
 304         <path value="DomainResource.contained" />
 305         <min value="0" />
 306         <max value="*" />
 307       </base>
 308       <type>
 309         <code value="Resource" />
 310       </type>
 311       <condition value="dom-2" />
 312       <condition value="dom-4" />
 313       <condition value="dom-3" />
 314       <condition value="dom-5" />
 315       <mustSupport value="false" />
 316       <isModifier value="false" />
 317       <isSummary value="false" />
 318       <mapping>
 319         <identity value="rim" />
 320         <map value="N/A" />
 321       </mapping>
 322     </element>
 323     <element id="DeviceDefinition.extension">
 324       <path value="DeviceDefinition.extension" />
 325       <slicing>
 326         <discriminator>
 327           <type value="value" />
 328           <path value="url" />
 329         </discriminator>
 330         <ordered value="false" />
 331         <rules value="open" />
 332       </slicing>
 333       <short value="Extension" />
 334       <definition value="An Extension" />
 335       <min value="0" />
 336       <max value="*" />
 337       <base>
 338         <path value="DomainResource.extension" />
 339         <min value="0" />
 340         <max value="*" />
 341       </base>
 342       <type>
 343         <code value="Extension" />
 344       </type>
 345       <constraint>
 346         <key value="ele-1" />
 347         <severity value="error" />
 348         <human value="All FHIR elements must have a @value or children" />
 349         <expression value="hasValue() or (children().count() > id.count())" />
 350         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 351       </constraint>
 352       <constraint>
 353         <key value="ext-1" />
 354         <severity value="error" />
 355         <human value="Must have either extensions or value[x], not both" />
 356         <expression value="extension.exists() != value.exists()" />
 357         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
 358       </constraint>
 359       <mustSupport value="false" />
 360       <isModifier value="false" />
 361       <isSummary value="false" />
 362     </element>
 363     <element id="DeviceDefinition.extension:CatalogReference">
 364       <path value="DeviceDefinition.extension" />
 365       <sliceName value="CatalogReference" />
 366       <short value="Reference to a catalog" />
 367       <definition value="This extension to PlanDefinition, MedicationKnowledge and DeviceDefinition conveys the reference to a catalog containing the extended resource" />
 368       <min value="0" />
 369       <max value="*" />
 370       <base>
 371         <path value="DomainResource.extension" />
 372         <min value="0" />
 373         <max value="*" />
 374       </base>
 375       <type>
 376         <code value="Extension" />
 377         <profile value="http://hl7.org/fhir/uv/order-catalog/StructureDefinition/CatalogReference" />
 378       </type>
 379       <constraint>
 380         <key value="ele-1" />
 381         <severity value="error" />
 382         <human value="All FHIR elements must have a @value or children" />
 383         <expression value="hasValue() or (children().count() > id.count())" />
 384         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 385       </constraint>
 386       <constraint>
 387         <key value="ext-1" />
 388         <severity value="error" />
 389         <human value="Must have either extensions or value[x], not both" />
 390         <expression value="extension.exists() != value.exists()" />
 391         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
 392       </constraint>
 393       <mustSupport value="false" />
 394       <isModifier value="false" />
 395     </element>
 396     <element id="DeviceDefinition.modifierExtension">
 397       <path value="DeviceDefinition.modifierExtension" />
 398       <short value="Extensions that cannot be ignored" />
 399       <definition value="May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
 400       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
 401       <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)." />
 402       <alias value="extensions" />
 403       <alias value="user content" />
 404       <min value="0" />
 405       <max value="*" />
 406       <base>
 407         <path value="DomainResource.modifierExtension" />
 408         <min value="0" />
 409         <max value="*" />
 410       </base>
 411       <type>
 412         <code value="Extension" />
 413       </type>
 414       <constraint>
 415         <key value="ele-1" />
 416         <severity value="error" />
 417         <human value="All FHIR elements must have a @value or children" />
 418         <expression value="hasValue() or (children().count() > id.count())" />
 419         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 420       </constraint>
 421       <constraint>
 422         <key value="ext-1" />
 423         <severity value="error" />
 424         <human value="Must have either extensions or value[x], not both" />
 425         <expression value="extension.exists() != value.exists()" />
 426         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
 427       </constraint>
 428       <mustSupport value="false" />
 429       <isModifier value="true" />
 430       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them" />
 431       <isSummary value="true" />
 432       <mapping>
 433         <identity value="rim" />
 434         <map value="N/A" />
 435       </mapping>
 436     </element>
 437     <element id="DeviceDefinition.description">
 438       <path value="DeviceDefinition.description" />
 439       <short value="Additional information to describe the device" />
 440       <definition value="Additional information to describe the device." />
 441       <min value="0" />
 442       <max value="1" />
 443       <base>
 444         <path value="DeviceDefinition.description" />
 445         <min value="0" />
 446         <max value="1" />
 447       </base>
 448       <type>
 449         <code value="markdown" />
 450       </type>
 451       <constraint>
 452         <key value="ele-1" />
 453         <severity value="error" />
 454         <human value="All FHIR elements must have a @value or children" />
 455         <expression value="hasValue() or (children().count() > id.count())" />
 456         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 457       </constraint>
 458       <mustSupport value="true" />
 459       <isModifier value="false" />
 460       <isSummary value="false" />
 461       <mapping>
 462         <identity value="devicedefinition-to-eudamed" />
 463         <map value="FLD-UDID-175|Additional product description" />
 464       </mapping>
 465       <mapping>
 466         <identity value="devicedefinition-to-gudid" />
 467         <map value="Device Description" />
 468       </mapping>
 469     </element>
 470     <element id="DeviceDefinition.identifier">
 471       <path value="DeviceDefinition.identifier" />
 472       <short value="Instance identifier" />
 473       <definition value="This repeatable element is used in catalogs of devices to convey any kind of identifier assigned to the model of device, other than the primary UDI DI.
identifier may convey for instance, the secondary UDI-DI, the direct-marking UDI-DI, the unit-of-use UDI-DI or any additional non-UDI identifier." />
 474       <min value="0" />
 475       <max value="*" />
 476       <base>
 477         <path value="DeviceDefinition.identifier" />
 478         <min value="0" />
 479         <max value="*" />
 480       </base>
 481       <type>
 482         <code value="Identifier" />
 483       </type>
 484       <constraint>
 485         <key value="ele-1" />
 486         <severity value="error" />
 487         <human value="All FHIR elements must have a @value or children" />
 488         <expression value="hasValue() or (children().count() > id.count())" />
 489         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 490       </constraint>
 491       <mustSupport value="true" />
 492       <isModifier value="false" />
 493       <isSummary value="true" />
 494       <mapping>
 495         <identity value="devicedefinition-to-eudamed" />
 496         <map value="FLD-UDID-136|Secondary UDI - DI code [use = secondary, type = DISTID]; FLD-UDID-138|Direct Marking UDI-DI code [type = DIRECT-MARKING]; FLD-UDID-135|Unit of Use DI code [type = SINGLE-ITEM]" />
 497       </mapping>
 498       <mapping>
 499         <identity value="devicedefinition-to-gudid" />
 500         <map value="Secondary DI Number [use = secondary, type = DISTID]; DM DI Number [type = DIRECT-MARKING]; Unit of Use DI Number [type = SINGLE-ITEM]" />
 501       </mapping>
 502       <mapping>
 503         <identity value="w5" />
 504         <map value="FiveWs.identifier" />
 505       </mapping>
 506     </element>
 507     <element id="DeviceDefinition.udiDeviceIdentifier">
 508       <path value="DeviceDefinition.udiDeviceIdentifier" />
 509       <short value="Unique Device Identifier (UDI) Barcode string" />
 510       <definition value="Unique device identifier (UDI) assigned to device label or package.  Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold." />
 511       <min value="0" />
 512       <max value="*" />
 513       <base>
 514         <path value="DeviceDefinition.udiDeviceIdentifier" />
 515         <min value="0" />
 516         <max value="*" />
 517       </base>
 518       <type>
 519         <code value="BackboneElement" />
 520       </type>
 521       <constraint>
 522         <key value="ele-1" />
 523         <severity value="error" />
 524         <human value="All FHIR elements must have a @value or children" />
 525         <expression value="hasValue() or (children().count() > id.count())" />
 526         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 527       </constraint>
 528       <mustSupport value="true" />
 529       <isModifier value="false" />
 530       <isSummary value="false" />
 531     </element>
 532     <element id="DeviceDefinition.udiDeviceIdentifier.id">
 533       <path value="DeviceDefinition.udiDeviceIdentifier.id" />
 534       <representation value="xmlAttr" />
 535       <short value="Unique id for inter-element referencing" />
 536       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
 537       <min value="0" />
 538       <max value="1" />
 539       <base>
 540         <path value="Element.id" />
 541         <min value="0" />
 542         <max value="1" />
 543       </base>
 544       <type>
 545         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
 546           <valueUrl value="string" />
 547         </extension>
 548         <code value="http://hl7.org/fhirpath/System.String" />
 549       </type>
 550       <condition value="ele-1" />
 551       <isModifier value="false" />
 552       <isSummary value="false" />
 553       <mapping>
 554         <identity value="rim" />
 555         <map value="n/a" />
 556       </mapping>
 557     </element>
 558     <element id="DeviceDefinition.udiDeviceIdentifier.extension">
 559       <path value="DeviceDefinition.udiDeviceIdentifier.extension" />
 560       <short value="Additional content defined by implementations" />
 561       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
 562       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
 563       <alias value="extensions" />
 564       <alias value="user content" />
 565       <min value="0" />
 566       <max value="*" />
 567       <base>
 568         <path value="Element.extension" />
 569         <min value="0" />
 570         <max value="*" />
 571       </base>
 572       <type>
 573         <code value="Extension" />
 574       </type>
 575       <constraint>
 576         <key value="ele-1" />
 577         <severity value="error" />
 578         <human value="All FHIR elements must have a @value or children" />
 579         <expression value="hasValue() or (children().count() > id.count())" />
 580         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 581       </constraint>
 582       <constraint>
 583         <key value="ext-1" />
 584         <severity value="error" />
 585         <human value="Must have either extensions or value[x], not both" />
 586         <expression value="extension.exists() != value.exists()" />
 587         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
 588       </constraint>
 589       <isModifier value="false" />
 590       <isSummary value="false" />
 591       <mapping>
 592         <identity value="rim" />
 593         <map value="n/a" />
 594       </mapping>
 595     </element>
 596     <element id="DeviceDefinition.udiDeviceIdentifier.modifierExtension">
 597       <path value="DeviceDefinition.udiDeviceIdentifier.modifierExtension" />
 598       <short value="Extensions that cannot be ignored even if unrecognized" />
 599       <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
 600       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
 601       <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)." />
 602       <alias value="extensions" />
 603       <alias value="user content" />
 604       <alias value="modifiers" />
 605       <min value="0" />
 606       <max value="*" />
 607       <base>
 608         <path value="BackboneElement.modifierExtension" />
 609         <min value="0" />
 610         <max value="*" />
 611       </base>
 612       <type>
 613         <code value="Extension" />
 614       </type>
 615       <constraint>
 616         <key value="ele-1" />
 617         <severity value="error" />
 618         <human value="All FHIR elements must have a @value or children" />
 619         <expression value="hasValue() or (children().count() > id.count())" />
 620         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 621       </constraint>
 622       <constraint>
 623         <key value="ext-1" />
 624         <severity value="error" />
 625         <human value="Must have either extensions or value[x], not both" />
 626         <expression value="extension.exists() != value.exists()" />
 627         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
 628       </constraint>
 629       <isModifier value="true" />
 630       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
 631       <isSummary value="true" />
 632       <mapping>
 633         <identity value="rim" />
 634         <map value="N/A" />
 635       </mapping>
 636     </element>
 637     <element id="DeviceDefinition.udiDeviceIdentifier.deviceIdentifier">
 638       <path value="DeviceDefinition.udiDeviceIdentifier.deviceIdentifier" />
 639       <short value="The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier" />
 640       <definition value="The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier." />
 641       <min value="1" />
 642       <max value="1" />
 643       <base>
 644         <path value="DeviceDefinition.udiDeviceIdentifier.deviceIdentifier" />
 645         <min value="1" />
 646         <max value="1" />
 647       </base>
 648       <type>
 649         <code value="string" />
 650       </type>
 651       <constraint>
 652         <key value="ele-1" />
 653         <severity value="error" />
 654         <human value="All FHIR elements must have a @value or children" />
 655         <expression value="hasValue() or (children().count() > id.count())" />
 656         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 657       </constraint>
 658       <mustSupport value="false" />
 659       <isModifier value="false" />
 660       <isSummary value="false" />
 661       <mapping>
 662         <identity value="devicedefinition-to-eudamed" />
 663         <map value="FLD-UDID-178|UDI-DI code" />
 664       </mapping>
 665       <mapping>
 666         <identity value="devicedefinition-to-gudid" />
 667         <map value="Primary DI Number" />
 668       </mapping>
 669     </element>
 670     <element id="DeviceDefinition.udiDeviceIdentifier.issuer">
 671       <path value="DeviceDefinition.udiDeviceIdentifier.issuer" />
 672       <short value="The organization that assigns the identifier algorithm" />
 673       <definition value="Organization accredited by the jurisdictional authority to operate a system for the issuance of UDIs. Main issuers referenced in the US and/or in EU include:
1. GS1 GTIN: urn:oid:1.3.160,
2. HIBCC: urn:oid:2.16.840.1.113883.6.40,
3. ICCBBA Information Standard for Blood and Transplant (ISBT) 128: urn:oid:2.16.840.1.113883.6.18,
4. ICCBBA for other devices: to be found,
5. IFA (Europe Union only): to be found" />
 674       <min value="1" />
 675       <max value="1" />
 676       <base>
 677         <path value="DeviceDefinition.udiDeviceIdentifier.issuer" />
 678         <min value="1" />
 679         <max value="1" />
 680       </base>
 681       <type>
 682         <code value="uri" />
 683       </type>
 684       <constraint>
 685         <key value="ele-1" />
 686         <severity value="error" />
 687         <human value="All FHIR elements must have a @value or children" />
 688         <expression value="hasValue() or (children().count() > id.count())" />
 689         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 690       </constraint>
 691       <mustSupport value="false" />
 692       <isModifier value="false" />
 693       <isSummary value="false" />
 694       <mapping>
 695         <identity value="devicedefinition-to-eudamed" />
 696         <map value="FLD-UDID-291|Issuing Entity UDI-DI" />
 697       </mapping>
 698       <mapping>
 699         <identity value="devicedefinition-to-gudid" />
 700         <map value="Primary DI Number - Issuing Agency" />
 701       </mapping>
 702     </element>
 703     <element id="DeviceDefinition.udiDeviceIdentifier.jurisdiction">
 704       <path value="DeviceDefinition.udiDeviceIdentifier.jurisdiction" />
 705       <short value="The jurisdiction to which the deviceIdentifier applies" />
 706       <definition value="The jurisdiction to which the deviceIdentifier applies. Known jurisdictions are:
1. US Food & Drug Administration (FDA): urn:oid:2.16.840.1.113883.3.150,
2. Europe Union EUDAMED: https://ec.europa.eu/health/medical-devices-sector_en" />
 707       <min value="1" />
 708       <max value="1" />
 709       <base>
 710         <path value="DeviceDefinition.udiDeviceIdentifier.jurisdiction" />
 711         <min value="1" />
 712         <max value="1" />
 713       </base>
 714       <type>
 715         <code value="uri" />
 716       </type>
 717       <constraint>
 718         <key value="ele-1" />
 719         <severity value="error" />
 720         <human value="All FHIR elements must have a @value or children" />
 721         <expression value="hasValue() or (children().count() > id.count())" />
 722         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 723       </constraint>
 724       <mustSupport value="false" />
 725       <isModifier value="false" />
 726       <isSummary value="false" />
 727       <mapping>
 728         <identity value="devicedefinition-to-eudamed" />
 729         <map value="https://ec.europa.eu/health/medical-devices-sector_en" />
 730       </mapping>
 731       <mapping>
 732         <identity value="devicedefinition-to-gudid" />
 733         <map value="urn:oid:2.16.840.1.113883.3.150" />
 734       </mapping>
 735     </element>
 736     <element id="DeviceDefinition.udiDeviceIdentifier.marketDistribution">
 737       <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution" />
 738       <short value="Indicates whether and when the device is available on the market" />
 739       <definition value="Indicates where and when the device is available on the market." />
 740       <min value="0" />
 741       <max value="*" />
 742       <base>
 743         <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution" />
 744         <min value="0" />
 745         <max value="*" />
 746       </base>
 747       <type>
 748         <code value="BackboneElement" />
 749       </type>
 750       <constraint>
 751         <key value="ele-1" />
 752         <severity value="error" />
 753         <human value="All FHIR elements must have a @value or children" />
 754         <expression value="hasValue() or (children().count() > id.count())" />
 755         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 756       </constraint>
 757       <mustSupport value="true" />
 758       <isModifier value="false" />
 759       <isSummary value="false" />
 760     </element>
 761     <element id="DeviceDefinition.udiDeviceIdentifier.marketDistribution.id">
 762       <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution.id" />
 763       <representation value="xmlAttr" />
 764       <short value="Unique id for inter-element referencing" />
 765       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
 766       <min value="0" />
 767       <max value="1" />
 768       <base>
 769         <path value="Element.id" />
 770         <min value="0" />
 771         <max value="1" />
 772       </base>
 773       <type>
 774         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
 775           <valueUrl value="string" />
 776         </extension>
 777         <code value="http://hl7.org/fhirpath/System.String" />
 778       </type>
 779       <condition value="ele-1" />
 780       <isModifier value="false" />
 781       <isSummary value="false" />
 782       <mapping>
 783         <identity value="rim" />
 784         <map value="n/a" />
 785       </mapping>
 786     </element>
 787     <element id="DeviceDefinition.udiDeviceIdentifier.marketDistribution.extension">
 788       <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution.extension" />
 789       <short value="Additional content defined by implementations" />
 790       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
 791       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
 792       <alias value="extensions" />
 793       <alias value="user content" />
 794       <min value="0" />
 795       <max value="*" />
 796       <base>
 797         <path value="Element.extension" />
 798         <min value="0" />
 799         <max value="*" />
 800       </base>
 801       <type>
 802         <code value="Extension" />
 803       </type>
 804       <constraint>
 805         <key value="ele-1" />
 806         <severity value="error" />
 807         <human value="All FHIR elements must have a @value or children" />
 808         <expression value="hasValue() or (children().count() > id.count())" />
 809         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 810       </constraint>
 811       <constraint>
 812         <key value="ext-1" />
 813         <severity value="error" />
 814         <human value="Must have either extensions or value[x], not both" />
 815         <expression value="extension.exists() != value.exists()" />
 816         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
 817       </constraint>
 818       <isModifier value="false" />
 819       <isSummary value="false" />
 820       <mapping>
 821         <identity value="rim" />
 822         <map value="n/a" />
 823       </mapping>
 824     </element>
 825     <element id="DeviceDefinition.udiDeviceIdentifier.marketDistribution.modifierExtension">
 826       <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution.modifierExtension" />
 827       <short value="Extensions that cannot be ignored even if unrecognized" />
 828       <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
 829       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
 830       <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)." />
 831       <alias value="extensions" />
 832       <alias value="user content" />
 833       <alias value="modifiers" />
 834       <min value="0" />
 835       <max value="*" />
 836       <base>
 837         <path value="BackboneElement.modifierExtension" />
 838         <min value="0" />
 839         <max value="*" />
 840       </base>
 841       <type>
 842         <code value="Extension" />
 843       </type>
 844       <constraint>
 845         <key value="ele-1" />
 846         <severity value="error" />
 847         <human value="All FHIR elements must have a @value or children" />
 848         <expression value="hasValue() or (children().count() > id.count())" />
 849         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 850       </constraint>
 851       <constraint>
 852         <key value="ext-1" />
 853         <severity value="error" />
 854         <human value="Must have either extensions or value[x], not both" />
 855         <expression value="extension.exists() != value.exists()" />
 856         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
 857       </constraint>
 858       <isModifier value="true" />
 859       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
 860       <isSummary value="true" />
 861       <mapping>
 862         <identity value="rim" />
 863         <map value="N/A" />
 864       </mapping>
 865     </element>
 866     <element id="DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod">
 867       <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod" />
 868       <short value="Begin and end dates for the commercial distribution of the device" />
 869       <definition value="Begin and end dates for the commercial distribution of the device." />
 870       <min value="1" />
 871       <max value="1" />
 872       <base>
 873         <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod" />
 874         <min value="1" />
 875         <max value="1" />
 876       </base>
 877       <type>
 878         <code value="Period" />
 879       </type>
 880       <constraint>
 881         <key value="ele-1" />
 882         <severity value="error" />
 883         <human value="All FHIR elements must have a @value or children" />
 884         <expression value="hasValue() or (children().count() > id.count())" />
 885         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 886       </constraint>
 887       <mustSupport value="false" />
 888       <isModifier value="false" />
 889       <isSummary value="false" />
 890     </element>
 891     <element id="DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.id">
 892       <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.id" />
 893       <representation value="xmlAttr" />
 894       <short value="Unique id for inter-element referencing" />
 895       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
 896       <min value="0" />
 897       <max value="1" />
 898       <base>
 899         <path value="Element.id" />
 900         <min value="0" />
 901         <max value="1" />
 902       </base>
 903       <type>
 904         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
 905           <valueUrl value="id" />
 906         </extension>
 907         <code value="http://hl7.org/fhirpath/System.String" />
 908       </type>
 909       <condition value="ele-1" />
 910       <isModifier value="false" />
 911       <isSummary value="false" />
 912       <mapping>
 913         <identity value="rim" />
 914         <map value="n/a" />
 915       </mapping>
 916     </element>
 917     <element id="DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.extension">
 918       <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.extension" />
 919       <slicing>
 920         <discriminator>
 921           <type value="value" />
 922           <path value="url" />
 923         </discriminator>
 924         <description value="Extensions are always sliced by (at least) url" />
 925         <rules value="open" />
 926       </slicing>
 927       <short value="Additional content defined by implementations" />
 928       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
 929       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
 930       <alias value="extensions" />
 931       <alias value="user content" />
 932       <min value="0" />
 933       <max value="*" />
 934       <base>
 935         <path value="Element.extension" />
 936         <min value="0" />
 937         <max value="*" />
 938       </base>
 939       <type>
 940         <code value="Extension" />
 941       </type>
 942       <constraint>
 943         <key value="ele-1" />
 944         <severity value="error" />
 945         <human value="All FHIR elements must have a @value or children" />
 946         <expression value="hasValue() or (children().count() > id.count())" />
 947         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 948       </constraint>
 949       <constraint>
 950         <key value="ext-1" />
 951         <severity value="error" />
 952         <human value="Must have either extensions or value[x], not both" />
 953         <expression value="extension.exists() != value.exists()" />
 954         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
 955       </constraint>
 956       <isModifier value="false" />
 957       <isSummary value="false" />
 958       <mapping>
 959         <identity value="rim" />
 960         <map value="n/a" />
 961       </mapping>
 962     </element>
 963     <element id="DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.start">
 964       <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.start" />
 965       <short value="Starting time with inclusive boundary" />
 966       <definition value="The start of the period. The boundary is inclusive." />
 967       <comment value="If the low element is missing, the meaning is that the low boundary is not known." />
 968       <min value="0" />
 969       <max value="1" />
 970       <base>
 971         <path value="Period.start" />
 972         <min value="0" />
 973         <max value="1" />
 974       </base>
 975       <type>
 976         <code value="dateTime" />
 977       </type>
 978       <condition value="per-1" />
 979       <constraint>
 980         <key value="ele-1" />
 981         <severity value="error" />
 982         <human value="All FHIR elements must have a @value or children" />
 983         <expression value="hasValue() or (children().count() > id.count())" />
 984         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 985       </constraint>
 986       <isModifier value="false" />
 987       <isSummary value="true" />
 988       <mapping>
 989         <identity value="devicedefinition-to-eudamed" />
 990         <map value="FLD-UDID-250|Start date" />
 991       </mapping>
 992       <mapping>
 993         <identity value="devicedefinition-to-gudid" />
 994         <map value="DEVICE RECORD STATUS - DI Record Publish Date" />
 995       </mapping>
 996       <mapping>
 997         <identity value="v2" />
 998         <map value="DR.1" />
 999       </mapping>
1000       <mapping>
1001         <identity value="rim" />
1002         <map value="./low" />
1003       </mapping>
1004     </element>
1005     <element id="DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.end">
1006       <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.end" />
1007       <short value="End time with inclusive boundary, if not ongoing" />
1008       <definition value="The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time." />
1009       <comment value="The end value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03." />
1010       <min value="0" />
1011       <max value="1" />
1012       <base>
1013         <path value="Period.end" />
1014         <min value="0" />
1015         <max value="1" />
1016       </base>
1017       <type>
1018         <code value="dateTime" />
1019       </type>
1020       <meaningWhenMissing value="If the end of the period is missing, it means that the period is ongoing" />
1021       <condition value="per-1" />
1022       <constraint>
1023         <key value="ele-1" />
1024         <severity value="error" />
1025         <human value="All FHIR elements must have a @value or children" />
1026         <expression value="hasValue() or (children().count() > id.count())" />
1027         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1028       </constraint>
1029       <isModifier value="false" />
1030       <isSummary value="true" />
1031       <mapping>
1032         <identity value="devicedefinition-to-eudamed" />
1033         <map value="FLD-UDID-251|End date" />
1034       </mapping>
1035       <mapping>
1036         <identity value="devicedefinition-to-gudid" />
1037         <map value="Commercial Distribution End Date" />
1038       </mapping>
1039       <mapping>
1040         <identity value="v2" />
1041         <map value="DR.2" />
1042       </mapping>
1043       <mapping>
1044         <identity value="rim" />
1045         <map value="./high" />
1046       </mapping>
1047     </element>
1048     <element id="DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction">
1049       <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction" />
1050       <short value="National state or territory where the device is commercialized" />
1051       <definition value="National state or territory to which the marketDistribution recers, typically where the device is commercialized." />
1052       <min value="1" />
1053       <max value="1" />
1054       <base>
1055         <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction" />
1056         <min value="1" />
1057         <max value="1" />
1058       </base>
1059       <type>
1060         <code value="uri" />
1061       </type>
1062       <constraint>
1063         <key value="ele-1" />
1064         <severity value="error" />
1065         <human value="All FHIR elements must have a @value or children" />
1066         <expression value="hasValue() or (children().count() > id.count())" />
1067         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1068       </constraint>
1069       <mustSupport value="false" />
1070       <isModifier value="false" />
1071       <isSummary value="false" />
1072       <mapping>
1073         <identity value="devicedefinition-to-eudamed" />
1074         <map value="FLD-UDID-141|Countries were the devices is made available" />
1075       </mapping>
1076       <mapping>
1077         <identity value="devicedefinition-to-gudid" />
1078         <map value="urn:oid:2.16.840.1.113883.3.150" />
1079       </mapping>
1080     </element>
1081     <element id="DeviceDefinition.regulatoryIdentifier">
1082       <path value="DeviceDefinition.regulatoryIdentifier" />
1083       <short value="Regulatory identifier(s) associated with this device" />
1084       <definition value="Identifier associated with the regulatory documentation (certificates, technical documentation, post-market surveillance documentation and reports) of a set of device models sharing the same intended purpose, risk class and essential design and manufacturing characteristics. One example is the Basic UDI-DI in Europe." />
1085       <comment value="This should not be used for regulatory authorization numbers which are to be captured elsewhere." />
1086       <min value="0" />
1087       <max value="*" />
1088       <base>
1089         <path value="DeviceDefinition.regulatoryIdentifier" />
1090         <min value="0" />
1091         <max value="*" />
1092       </base>
1093       <type>
1094         <code value="BackboneElement" />
1095       </type>
1096       <constraint>
1097         <key value="ele-1" />
1098         <severity value="error" />
1099         <human value="All FHIR elements must have a @value or children" />
1100         <expression value="hasValue() or (children().count() > id.count())" />
1101         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1102       </constraint>
1103       <mustSupport value="false" />
1104       <isModifier value="false" />
1105       <isSummary value="false" />
1106     </element>
1107     <element id="DeviceDefinition.regulatoryIdentifier.id">
1108       <path value="DeviceDefinition.regulatoryIdentifier.id" />
1109       <representation value="xmlAttr" />
1110       <short value="Unique id for inter-element referencing" />
1111       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
1112       <min value="0" />
1113       <max value="1" />
1114       <base>
1115         <path value="Element.id" />
1116         <min value="0" />
1117         <max value="1" />
1118       </base>
1119       <type>
1120         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
1121           <valueUrl value="string" />
1122         </extension>
1123         <code value="http://hl7.org/fhirpath/System.String" />
1124       </type>
1125       <condition value="ele-1" />
1126       <isModifier value="false" />
1127       <isSummary value="false" />
1128       <mapping>
1129         <identity value="rim" />
1130         <map value="n/a" />
1131       </mapping>
1132     </element>
1133     <element id="DeviceDefinition.regulatoryIdentifier.extension">
1134       <path value="DeviceDefinition.regulatoryIdentifier.extension" />
1135       <short value="Additional content defined by implementations" />
1136       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
1137       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
1138       <alias value="extensions" />
1139       <alias value="user content" />
1140       <min value="0" />
1141       <max value="*" />
1142       <base>
1143         <path value="Element.extension" />
1144         <min value="0" />
1145         <max value="*" />
1146       </base>
1147       <type>
1148         <code value="Extension" />
1149       </type>
1150       <constraint>
1151         <key value="ele-1" />
1152         <severity value="error" />
1153         <human value="All FHIR elements must have a @value or children" />
1154         <expression value="hasValue() or (children().count() > id.count())" />
1155         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1156       </constraint>
1157       <constraint>
1158         <key value="ext-1" />
1159         <severity value="error" />
1160         <human value="Must have either extensions or value[x], not both" />
1161         <expression value="extension.exists() != value.exists()" />
1162         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
1163       </constraint>
1164       <isModifier value="false" />
1165       <isSummary value="false" />
1166       <mapping>
1167         <identity value="rim" />
1168         <map value="n/a" />
1169       </mapping>
1170     </element>
1171     <element id="DeviceDefinition.regulatoryIdentifier.modifierExtension">
1172       <path value="DeviceDefinition.regulatoryIdentifier.modifierExtension" />
1173       <short value="Extensions that cannot be ignored even if unrecognized" />
1174       <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
1175       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
1176       <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)." />
1177       <alias value="extensions" />
1178       <alias value="user content" />
1179       <alias value="modifiers" />
1180       <min value="0" />
1181       <max value="*" />
1182       <base>
1183         <path value="BackboneElement.modifierExtension" />
1184         <min value="0" />
1185         <max value="*" />
1186       </base>
1187       <type>
1188         <code value="Extension" />
1189       </type>
1190       <constraint>
1191         <key value="ele-1" />
1192         <severity value="error" />
1193         <human value="All FHIR elements must have a @value or children" />
1194         <expression value="hasValue() or (children().count() > id.count())" />
1195         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1196       </constraint>
1197       <constraint>
1198         <key value="ext-1" />
1199         <severity value="error" />
1200         <human value="Must have either extensions or value[x], not both" />
1201         <expression value="extension.exists() != value.exists()" />
1202         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
1203       </constraint>
1204       <isModifier value="true" />
1205       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
1206       <isSummary value="true" />
1207       <mapping>
1208         <identity value="rim" />
1209         <map value="N/A" />
1210       </mapping>
1211     </element>
1212     <element id="DeviceDefinition.regulatoryIdentifier.type">
1213       <path value="DeviceDefinition.regulatoryIdentifier.type" />
1214       <short value="basic | master | license" />
1215       <definition value="The type of identifier itself." />
1216       <min value="1" />
1217       <max value="1" />
1218       <base>
1219         <path value="DeviceDefinition.regulatoryIdentifier.type" />
1220         <min value="1" />
1221         <max value="1" />
1222       </base>
1223       <type>
1224         <code value="code" />
1225       </type>
1226       <constraint>
1227         <key value="ele-1" />
1228         <severity value="error" />
1229         <human value="All FHIR elements must have a @value or children" />
1230         <expression value="hasValue() or (children().count() > id.count())" />
1231         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1232       </constraint>
1233       <mustSupport value="false" />
1234       <isModifier value="false" />
1235       <isSummary value="false" />
1236       <binding>
1237         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
1238           <valueString value="DeviceRegulatoryIdentifierType" />
1239         </extension>
1240         <strength value="required" />
1241         <description value="Device regulatory identifier type." />
1242         <valueSet value="http://hl7.org/fhir/ValueSet/devicedefinition-regulatory-identifier-type|5.0.0" />
1243       </binding>
1244     </element>
1245     <element id="DeviceDefinition.regulatoryIdentifier.deviceIdentifier">
1246       <path value="DeviceDefinition.regulatoryIdentifier.deviceIdentifier" />
1247       <short value="The identifier itself" />
1248       <definition value="The identifier itself." />
1249       <min value="1" />
1250       <max value="1" />
1251       <base>
1252         <path value="DeviceDefinition.regulatoryIdentifier.deviceIdentifier" />
1253         <min value="1" />
1254         <max value="1" />
1255       </base>
1256       <type>
1257         <code value="string" />
1258       </type>
1259       <constraint>
1260         <key value="ele-1" />
1261         <severity value="error" />
1262         <human value="All FHIR elements must have a @value or children" />
1263         <expression value="hasValue() or (children().count() > id.count())" />
1264         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1265       </constraint>
1266       <mustSupport value="false" />
1267       <isModifier value="false" />
1268       <isSummary value="false" />
1269     </element>
1270     <element id="DeviceDefinition.regulatoryIdentifier.issuer">
1271       <path value="DeviceDefinition.regulatoryIdentifier.issuer" />
1272       <short value="The organization that issued this identifier" />
1273       <definition value="The organization that issued this identifier." />
1274       <min value="1" />
1275       <max value="1" />
1276       <base>
1277         <path value="DeviceDefinition.regulatoryIdentifier.issuer" />
1278         <min value="1" />
1279         <max value="1" />
1280       </base>
1281       <type>
1282         <code value="uri" />
1283       </type>
1284       <constraint>
1285         <key value="ele-1" />
1286         <severity value="error" />
1287         <human value="All FHIR elements must have a @value or children" />
1288         <expression value="hasValue() or (children().count() > id.count())" />
1289         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1290       </constraint>
1291       <mustSupport value="false" />
1292       <isModifier value="false" />
1293       <isSummary value="false" />
1294     </element>
1295     <element id="DeviceDefinition.regulatoryIdentifier.jurisdiction">
1296       <path value="DeviceDefinition.regulatoryIdentifier.jurisdiction" />
1297       <short value="The jurisdiction to which the deviceIdentifier applies" />
1298       <definition value="The jurisdiction to which the deviceIdentifier applies." />
1299       <min value="1" />
1300       <max value="1" />
1301       <base>
1302         <path value="DeviceDefinition.regulatoryIdentifier.jurisdiction" />
1303         <min value="1" />
1304         <max value="1" />
1305       </base>
1306       <type>
1307         <code value="uri" />
1308       </type>
1309       <constraint>
1310         <key value="ele-1" />
1311         <severity value="error" />
1312         <human value="All FHIR elements must have a @value or children" />
1313         <expression value="hasValue() or (children().count() > id.count())" />
1314         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1315       </constraint>
1316       <mustSupport value="false" />
1317       <isModifier value="false" />
1318       <isSummary value="false" />
1319     </element>
1320     <element id="DeviceDefinition.partNumber">
1321       <path value="DeviceDefinition.partNumber" />
1322       <short value="The part number or catalog number of the device" />
1323       <definition value="The part number or catalog number of the device." />
1324       <comment value="Alphanumeric Maximum 20." />
1325       <min value="0" />
1326       <max value="1" />
1327       <base>
1328         <path value="DeviceDefinition.partNumber" />
1329         <min value="0" />
1330         <max value="1" />
1331       </base>
1332       <type>
1333         <code value="string" />
1334       </type>
1335       <constraint>
1336         <key value="ele-1" />
1337         <severity value="error" />
1338         <human value="All FHIR elements must have a @value or children" />
1339         <expression value="hasValue() or (children().count() > id.count())" />
1340         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1341       </constraint>
1342       <mustSupport value="true" />
1343       <isModifier value="false" />
1344       <isSummary value="false" />
1345       <mapping>
1346         <identity value="devicedefinition-to-eudamed" />
1347         <map value="FLD-UDID-163|Reference / Catalogue Number" />
1348       </mapping>
1349       <mapping>
1350         <identity value="devicedefinition-to-gudid" />
1351         <map value="Catalog Number" />
1352       </mapping>
1353       <mapping>
1354         <identity value="w5" />
1355         <map value="FiveWs.what[x]" />
1356       </mapping>
1357       <mapping>
1358         <identity value="rim" />
1359         <map value=".playedRole[typeCode=MANU].id" />
1360       </mapping>
1361     </element>
1362     <element id="DeviceDefinition.manufacturer">
1363       <path value="DeviceDefinition.manufacturer" />
1364       <short value="Name of device manufacturer" />
1365       <definition value="A name of the manufacturer  or legal representative e.g. labeler. Whether this is the actual manufacturer or the labeler or responsible depends on implementation and jurisdiction." />
1366       <min value="0" />
1367       <max value="1" />
1368       <base>
1369         <path value="DeviceDefinition.manufacturer" />
1370         <min value="0" />
1371         <max value="1" />
1372       </base>
1373       <type>
1374         <code value="Reference" />
1375         <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization" />
1376       </type>
1377       <constraint>
1378         <key value="ele-1" />
1379         <severity value="error" />
1380         <human value="All FHIR elements must have a @value or children" />
1381         <expression value="hasValue() or (children().count() > id.count())" />
1382         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1383       </constraint>
1384       <mustSupport value="true" />
1385       <isModifier value="false" />
1386       <isSummary value="true" />
1387       <mapping>
1388         <identity value="devicedefinition-to-eudamed" />
1389         <map value="FLD-UDID-10|Legal Manufacturer SRN" />
1390       </mapping>
1391       <mapping>
1392         <identity value="devicedefinition-to-gudid" />
1393         <map value="Company Name" />
1394       </mapping>
1395       <mapping>
1396         <identity value="w5" />
1397         <map value="FiveWs.what[x]" />
1398       </mapping>
1399       <mapping>
1400         <identity value="rim" />
1401         <map value=".playedRole[typeCode=MANU].scoper.name" />
1402       </mapping>
1403     </element>
1404     <element id="DeviceDefinition.deviceName">
1405       <path value="DeviceDefinition.deviceName" />
1406       <short value="The name or names of the device as given by the manufacturer" />
1407       <definition value="The name or names of the device as given by the manufacturer." />
1408       <min value="0" />
1409       <max value="*" />
1410       <base>
1411         <path value="DeviceDefinition.deviceName" />
1412         <min value="0" />
1413         <max value="*" />
1414       </base>
1415       <type>
1416         <code value="BackboneElement" />
1417       </type>
1418       <constraint>
1419         <key value="ele-1" />
1420         <severity value="error" />
1421         <human value="All FHIR elements must have a @value or children" />
1422         <expression value="hasValue() or (children().count() > id.count())" />
1423         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1424       </constraint>
1425       <mustSupport value="true" />
1426       <isModifier value="false" />
1427       <isSummary value="true" />
1428     </element>
1429     <element id="DeviceDefinition.deviceName.id">
1430       <path value="DeviceDefinition.deviceName.id" />
1431       <representation value="xmlAttr" />
1432       <short value="Unique id for inter-element referencing" />
1433       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
1434       <min value="0" />
1435       <max value="1" />
1436       <base>
1437         <path value="Element.id" />
1438         <min value="0" />
1439         <max value="1" />
1440       </base>
1441       <type>
1442         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
1443           <valueUrl value="string" />
1444         </extension>
1445         <code value="http://hl7.org/fhirpath/System.String" />
1446       </type>
1447       <condition value="ele-1" />
1448       <isModifier value="false" />
1449       <isSummary value="false" />
1450       <mapping>
1451         <identity value="rim" />
1452         <map value="n/a" />
1453       </mapping>
1454     </element>
1455     <element id="DeviceDefinition.deviceName.extension">
1456       <path value="DeviceDefinition.deviceName.extension" />
1457       <short value="Additional content defined by implementations" />
1458       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
1459       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
1460       <alias value="extensions" />
1461       <alias value="user content" />
1462       <min value="0" />
1463       <max value="*" />
1464       <base>
1465         <path value="Element.extension" />
1466         <min value="0" />
1467         <max value="*" />
1468       </base>
1469       <type>
1470         <code value="Extension" />
1471       </type>
1472       <constraint>
1473         <key value="ele-1" />
1474         <severity value="error" />
1475         <human value="All FHIR elements must have a @value or children" />
1476         <expression value="hasValue() or (children().count() > id.count())" />
1477         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1478       </constraint>
1479       <constraint>
1480         <key value="ext-1" />
1481         <severity value="error" />
1482         <human value="Must have either extensions or value[x], not both" />
1483         <expression value="extension.exists() != value.exists()" />
1484         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
1485       </constraint>
1486       <isModifier value="false" />
1487       <isSummary value="false" />
1488       <mapping>
1489         <identity value="rim" />
1490         <map value="n/a" />
1491       </mapping>
1492     </element>
1493     <element id="DeviceDefinition.deviceName.modifierExtension">
1494       <path value="DeviceDefinition.deviceName.modifierExtension" />
1495       <short value="Extensions that cannot be ignored even if unrecognized" />
1496       <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
1497       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
1498       <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)." />
1499       <alias value="extensions" />
1500       <alias value="user content" />
1501       <alias value="modifiers" />
1502       <min value="0" />
1503       <max value="*" />
1504       <base>
1505         <path value="BackboneElement.modifierExtension" />
1506         <min value="0" />
1507         <max value="*" />
1508       </base>
1509       <type>
1510         <code value="Extension" />
1511       </type>
1512       <constraint>
1513         <key value="ele-1" />
1514         <severity value="error" />
1515         <human value="All FHIR elements must have a @value or children" />
1516         <expression value="hasValue() or (children().count() > id.count())" />
1517         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1518       </constraint>
1519       <constraint>
1520         <key value="ext-1" />
1521         <severity value="error" />
1522         <human value="Must have either extensions or value[x], not both" />
1523         <expression value="extension.exists() != value.exists()" />
1524         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
1525       </constraint>
1526       <isModifier value="true" />
1527       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
1528       <isSummary value="true" />
1529       <mapping>
1530         <identity value="rim" />
1531         <map value="N/A" />
1532       </mapping>
1533     </element>
1534     <element id="DeviceDefinition.deviceName.name">
1535       <path value="DeviceDefinition.deviceName.name" />
1536       <short value="A name that is used to refer to the device" />
1537       <definition value="A human-friendly name that is used to refer to the device - depending on the type, it can be the brand name, the common name or alias, or other." />
1538       <alias value="Σ" />
1539       <min value="1" />
1540       <max value="1" />
1541       <base>
1542         <path value="DeviceDefinition.deviceName.name" />
1543         <min value="1" />
1544         <max value="1" />
1545       </base>
1546       <type>
1547         <code value="string" />
1548       </type>
1549       <constraint>
1550         <key value="ele-1" />
1551         <severity value="error" />
1552         <human value="All FHIR elements must have a @value or children" />
1553         <expression value="hasValue() or (children().count() > id.count())" />
1554         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1555       </constraint>
1556       <mustSupport value="false" />
1557       <isModifier value="false" />
1558       <isSummary value="true" />
1559       <mapping>
1560         <identity value="devicedefinition-to-eudamed" />
1561         <map value="FLD-UDID-22|Device Name" />
1562       </mapping>
1563       <mapping>
1564         <identity value="devicedefinition-to-gudid" />
1565         <map value="Brand Name" />
1566       </mapping>
1567     </element>
1568     <element id="DeviceDefinition.deviceName.type">
1569       <path value="DeviceDefinition.deviceName.type" />
1570       <short value="registered-name | user-friendly-name | patient-reported-name" />
1571       <definition value="The type of deviceName.
RegisteredName | UserFriendlyName | PatientReportedName." />
1572       <min value="1" />
1573       <max value="1" />
1574       <base>
1575         <path value="DeviceDefinition.deviceName.type" />
1576         <min value="1" />
1577         <max value="1" />
1578       </base>
1579       <type>
1580         <code value="code" />
1581       </type>
1582       <constraint>
1583         <key value="ele-1" />
1584         <severity value="error" />
1585         <human value="All FHIR elements must have a @value or children" />
1586         <expression value="hasValue() or (children().count() > id.count())" />
1587         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1588       </constraint>
1589       <mustSupport value="false" />
1590       <isModifier value="false" />
1591       <isSummary value="true" />
1592       <binding>
1593         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
1594           <valueString value="DeviceNameType" />
1595         </extension>
1596         <strength value="required" />
1597         <description value="The type of name the device is referred by." />
1598         <valueSet value="http://hl7.org/fhir/ValueSet/device-nametype|5.0.0" />
1599       </binding>
1600       <mapping>
1601         <identity value="devicedefinition-to-eudamed" />
1602         <map value="[registered-name]" />
1603       </mapping>
1604       <mapping>
1605         <identity value="devicedefinition-to-gudid" />
1606         <map value="[registered-name]" />
1607       </mapping>
1608       <mapping>
1609         <identity value="w5" />
1610         <map value="FiveWs.what[x]" />
1611       </mapping>
1612       <mapping>
1613         <identity value="rim" />
1614         <map value=".playedRole[typeCode=MANU].code" />
1615       </mapping>
1616     </element>
1617     <element id="DeviceDefinition.modelNumber">
1618       <path value="DeviceDefinition.modelNumber" />
1619       <short value="The catalog or model number for the device for example as defined by the manufacturer" />
1620       <definition value="The model number for the device for example as defined by the manufacturer or labeler, or other agency." />
1621       <min value="0" />
1622       <max value="1" />
1623       <base>
1624         <path value="DeviceDefinition.modelNumber" />
1625         <min value="0" />
1626         <max value="1" />
1627       </base>
1628       <type>
1629         <code value="string" />
1630       </type>
1631       <constraint>
1632         <key value="ele-1" />
1633         <severity value="error" />
1634         <human value="All FHIR elements must have a @value or children" />
1635         <expression value="hasValue() or (children().count() > id.count())" />
1636         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1637       </constraint>
1638       <mustSupport value="true" />
1639       <isModifier value="false" />
1640       <isSummary value="true" />
1641       <mapping>
1642         <identity value="devicedefinition-to-eudamed" />
1643         <map value="FLD-UDID-20|Device Model" />
1644       </mapping>
1645       <mapping>
1646         <identity value="devicedefinition-to-gudid" />
1647         <map value="Version or Model" />
1648       </mapping>
1649       <mapping>
1650         <identity value="w5" />
1651         <map value="FiveWs.what[x]" />
1652       </mapping>
1653       <mapping>
1654         <identity value="rim" />
1655         <map value=".softwareName (included as part)" />
1656       </mapping>
1657     </element>
1658     <element id="DeviceDefinition.classification">
1659       <path value="DeviceDefinition.classification" />
1660       <slicing>
1661         <discriminator>
1662           <type value="pattern" />
1663           <path value="type.coding.system" />
1664         </discriminator>
1665         <description value="Slice based on classification.type pattern" />
1666         <rules value="open" />
1667       </slicing>
1668       <short value="What kind of device or device system this is" />
1669       <definition value="What kind of device or device system this is." />
1670       <comment value="In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes." />
1671       <min value="0" />
1672       <max value="*" />
1673       <base>
1674         <path value="DeviceDefinition.classification" />
1675         <min value="0" />
1676         <max value="*" />
1677       </base>
1678       <type>
1679         <code value="BackboneElement" />
1680       </type>
1681       <constraint>
1682         <key value="ele-1" />
1683         <severity value="error" />
1684         <human value="All FHIR elements must have a @value or children" />
1685         <expression value="hasValue() or (children().count() > id.count())" />
1686         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1687       </constraint>
1688       <mustSupport value="false" />
1689       <isModifier value="false" />
1690       <isSummary value="true" />
1691     </element>
1692     <element id="DeviceDefinition.classification.id">
1693       <path value="DeviceDefinition.classification.id" />
1694       <representation value="xmlAttr" />
1695       <short value="Unique id for inter-element referencing" />
1696       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
1697       <min value="0" />
1698       <max value="1" />
1699       <base>
1700         <path value="Element.id" />
1701         <min value="0" />
1702         <max value="1" />
1703       </base>
1704       <type>
1705         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
1706           <valueUrl value="string" />
1707         </extension>
1708         <code value="http://hl7.org/fhirpath/System.String" />
1709       </type>
1710       <condition value="ele-1" />
1711       <isModifier value="false" />
1712       <isSummary value="false" />
1713       <mapping>
1714         <identity value="rim" />
1715         <map value="n/a" />
1716       </mapping>
1717     </element>
1718     <element id="DeviceDefinition.classification.extension">
1719       <path value="DeviceDefinition.classification.extension" />
1720       <short value="Additional content defined by implementations" />
1721       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
1722       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
1723       <alias value="extensions" />
1724       <alias value="user content" />
1725       <min value="0" />
1726       <max value="*" />
1727       <base>
1728         <path value="Element.extension" />
1729         <min value="0" />
1730         <max value="*" />
1731       </base>
1732       <type>
1733         <code value="Extension" />
1734       </type>
1735       <constraint>
1736         <key value="ele-1" />
1737         <severity value="error" />
1738         <human value="All FHIR elements must have a @value or children" />
1739         <expression value="hasValue() or (children().count() > id.count())" />
1740         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1741       </constraint>
1742       <constraint>
1743         <key value="ext-1" />
1744         <severity value="error" />
1745         <human value="Must have either extensions or value[x], not both" />
1746         <expression value="extension.exists() != value.exists()" />
1747         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
1748       </constraint>
1749       <isModifier value="false" />
1750       <isSummary value="false" />
1751       <mapping>
1752         <identity value="rim" />
1753         <map value="n/a" />
1754       </mapping>
1755     </element>
1756     <element id="DeviceDefinition.classification.modifierExtension">
1757       <path value="DeviceDefinition.classification.modifierExtension" />
1758       <short value="Extensions that cannot be ignored even if unrecognized" />
1759       <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
1760       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
1761       <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)." />
1762       <alias value="extensions" />
1763       <alias value="user content" />
1764       <alias value="modifiers" />
1765       <min value="0" />
1766       <max value="*" />
1767       <base>
1768         <path value="BackboneElement.modifierExtension" />
1769         <min value="0" />
1770         <max value="*" />
1771       </base>
1772       <type>
1773         <code value="Extension" />
1774       </type>
1775       <constraint>
1776         <key value="ele-1" />
1777         <severity value="error" />
1778         <human value="All FHIR elements must have a @value or children" />
1779         <expression value="hasValue() or (children().count() > id.count())" />
1780         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1781       </constraint>
1782       <constraint>
1783         <key value="ext-1" />
1784         <severity value="error" />
1785         <human value="Must have either extensions or value[x], not both" />
1786         <expression value="extension.exists() != value.exists()" />
1787         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
1788       </constraint>
1789       <isModifier value="true" />
1790       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
1791       <isSummary value="true" />
1792       <mapping>
1793         <identity value="rim" />
1794         <map value="N/A" />
1795       </mapping>
1796     </element>
1797     <element id="DeviceDefinition.classification.type">
1798       <path value="DeviceDefinition.classification.type" />
1799       <short value="A classification or risk class of the device model" />
1800       <definition value="A classification or risk class of the device model." />
1801       <min value="1" />
1802       <max value="1" />
1803       <base>
1804         <path value="DeviceDefinition.classification.type" />
1805         <min value="1" />
1806         <max value="1" />
1807       </base>
1808       <type>
1809         <code value="CodeableConcept" />
1810       </type>
1811       <constraint>
1812         <key value="ele-1" />
1813         <severity value="error" />
1814         <human value="All FHIR elements must have a @value or children" />
1815         <expression value="hasValue() or (children().count() > id.count())" />
1816         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1817       </constraint>
1818       <mustSupport value="false" />
1819       <isModifier value="false" />
1820       <isSummary value="true" />
1821       <binding>
1822         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
1823           <valueString value="DeviceKind" />
1824         </extension>
1825         <strength value="example" />
1826         <description value="Type of device e.g. according to official classification." />
1827         <valueSet value="http://hl7.org/fhir/ValueSet/device-type" />
1828       </binding>
1829     </element>
1830     <element id="DeviceDefinition.classification.justification">
1831       <path value="DeviceDefinition.classification.justification" />
1832       <short value="Further information qualifying this classification of the device model" />
1833       <definition value="Further information qualifying this classification of the device model." />
1834       <min value="0" />
1835       <max value="*" />
1836       <base>
1837         <path value="DeviceDefinition.classification.justification" />
1838         <min value="0" />
1839         <max value="*" />
1840       </base>
1841       <type>
1842         <code value="RelatedArtifact" />
1843       </type>
1844       <constraint>
1845         <key value="ele-1" />
1846         <severity value="error" />
1847         <human value="All FHIR elements must have a @value or children" />
1848         <expression value="hasValue() or (children().count() > id.count())" />
1849         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1850       </constraint>
1851       <mustSupport value="false" />
1852       <isModifier value="false" />
1853       <isSummary value="false" />
1854     </element>
1855     <element id="DeviceDefinition.classification:gmdn">
1856       <path value="DeviceDefinition.classification" />
1857       <sliceName value="gmdn" />
1858       <short value="GMDN classification" />
1859       <definition value="Global Medical Device Nomenclature classification" />
1860       <comment value="In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes." />
1861       <min value="0" />
1862       <max value="*" />
1863       <base>
1864         <path value="DeviceDefinition.classification" />
1865         <min value="0" />
1866         <max value="*" />
1867       </base>
1868       <type>
1869         <code value="BackboneElement" />
1870       </type>
1871       <constraint>
1872         <key value="ele-1" />
1873         <severity value="error" />
1874         <human value="All FHIR elements must have a @value or children" />
1875         <expression value="hasValue() or (children().count() > id.count())" />
1876         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1877       </constraint>
1878       <mustSupport value="false" />
1879       <isModifier value="false" />
1880       <isSummary value="true" />
1881     </element>
1882     <element id="DeviceDefinition.classification:gmdn.id">
1883       <path value="DeviceDefinition.classification.id" />
1884       <representation value="xmlAttr" />
1885       <short value="Unique id for inter-element referencing" />
1886       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
1887       <min value="0" />
1888       <max value="1" />
1889       <base>
1890         <path value="Element.id" />
1891         <min value="0" />
1892         <max value="1" />
1893       </base>
1894       <type>
1895         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
1896           <valueUrl value="string" />
1897         </extension>
1898         <code value="http://hl7.org/fhirpath/System.String" />
1899       </type>
1900       <condition value="ele-1" />
1901       <isModifier value="false" />
1902       <isSummary value="false" />
1903       <mapping>
1904         <identity value="rim" />
1905         <map value="n/a" />
1906       </mapping>
1907     </element>
1908     <element id="DeviceDefinition.classification:gmdn.extension">
1909       <path value="DeviceDefinition.classification.extension" />
1910       <short value="Additional content defined by implementations" />
1911       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
1912       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
1913       <alias value="extensions" />
1914       <alias value="user content" />
1915       <min value="0" />
1916       <max value="*" />
1917       <base>
1918         <path value="Element.extension" />
1919         <min value="0" />
1920         <max value="*" />
1921       </base>
1922       <type>
1923         <code value="Extension" />
1924       </type>
1925       <constraint>
1926         <key value="ele-1" />
1927         <severity value="error" />
1928         <human value="All FHIR elements must have a @value or children" />
1929         <expression value="hasValue() or (children().count() > id.count())" />
1930         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1931       </constraint>
1932       <constraint>
1933         <key value="ext-1" />
1934         <severity value="error" />
1935         <human value="Must have either extensions or value[x], not both" />
1936         <expression value="extension.exists() != value.exists()" />
1937         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
1938       </constraint>
1939       <isModifier value="false" />
1940       <isSummary value="false" />
1941       <mapping>
1942         <identity value="rim" />
1943         <map value="n/a" />
1944       </mapping>
1945     </element>
1946     <element id="DeviceDefinition.classification:gmdn.modifierExtension">
1947       <path value="DeviceDefinition.classification.modifierExtension" />
1948       <short value="Extensions that cannot be ignored even if unrecognized" />
1949       <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
1950       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
1951       <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)." />
1952       <alias value="extensions" />
1953       <alias value="user content" />
1954       <alias value="modifiers" />
1955       <min value="0" />
1956       <max value="*" />
1957       <base>
1958         <path value="BackboneElement.modifierExtension" />
1959         <min value="0" />
1960         <max value="*" />
1961       </base>
1962       <type>
1963         <code value="Extension" />
1964       </type>
1965       <constraint>
1966         <key value="ele-1" />
1967         <severity value="error" />
1968         <human value="All FHIR elements must have a @value or children" />
1969         <expression value="hasValue() or (children().count() > id.count())" />
1970         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1971       </constraint>
1972       <constraint>
1973         <key value="ext-1" />
1974         <severity value="error" />
1975         <human value="Must have either extensions or value[x], not both" />
1976         <expression value="extension.exists() != value.exists()" />
1977         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
1978       </constraint>
1979       <isModifier value="true" />
1980       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
1981       <isSummary value="true" />
1982       <mapping>
1983         <identity value="rim" />
1984         <map value="N/A" />
1985       </mapping>
1986     </element>
1987     <element id="DeviceDefinition.classification:gmdn.type">
1988       <path value="DeviceDefinition.classification.type" />
1989       <short value="A classification or risk class of the device model" />
1990       <definition value="A classification or risk class of the device model." />
1991       <min value="1" />
1992       <max value="1" />
1993       <base>
1994         <path value="DeviceDefinition.classification.type" />
1995         <min value="1" />
1996         <max value="1" />
1997       </base>
1998       <type>
1999         <code value="CodeableConcept" />
2000       </type>
2001       <constraint>
2002         <key value="ele-1" />
2003         <severity value="error" />
2004         <human value="All FHIR elements must have a @value or children" />
2005         <expression value="hasValue() or (children().count() > id.count())" />
2006         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
2007       </constraint>
2008       <mustSupport value="false" />
2009       <isModifier value="false" />
2010       <isSummary value="true" />
2011       <binding>
2012         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
2013           <valueString value="DeviceKind" />
2014         </extension>
2015         <strength value="example" />
2016         <description value="Type of device e.g. according to official classification." />
2017         <valueSet value="http://hl7.org/fhir/ValueSet/device-type" />
2018       </binding>
2019     </element>
2020     <element id="DeviceDefinition.classification:gmdn.type.id">
2021       <path value="DeviceDefinition.classification.type.id" />
2022       <representation value="xmlAttr" />
2023       <short value="Unique id for inter-element referencing" />
2024       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
2025       <min value="0" />
2026       <max value="1" />
2027       <base>
2028         <path value="Element.id" />
2029         <min value="0" />
2030         <max value="1" />
2031       </base>
2032       <type>
2033         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
2034           <valueUrl value="id" />
2035         </extension>
2036         <code value="http://hl7.org/fhirpath/System.String" />
2037       </type>
2038       <condition value="ele-1" />
2039       <isModifier value="false" />
2040       <isSummary value="false" />
2041       <mapping>
2042         <identity value="rim" />
2043         <map value="n/a" />
2044       </mapping>
2045     </element>
2046     <element id="DeviceDefinition.classification:gmdn.type.extension">
2047       <path value="DeviceDefinition.classification.type.extension" />
2048       <slicing>
2049         <discriminator>
2050           <type value="value" />
2051           <path value="url" />
2052         </discriminator>
2053         <description value="Extensions are always sliced by (at least) url" />
2054         <rules value="open" />
2055       </slicing>
2056       <short value="Additional content defined by implementations" />
2057       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
2058       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
2059       <alias value="extensions" />
2060       <alias value="user content" />
2061       <min value="0" />
2062       <max value="*" />
2063       <base>
2064         <path value="Element.extension" />
2065         <min value="0" />
2066         <max value="*" />
2067       </base>
2068       <type>
2069         <code value="Extension" />
2070       </type>
2071       <constraint>
2072         <key value="ele-1" />
2073         <severity value="error" />
2074         <human value="All FHIR elements must have a @value or children" />
2075         <expression value="hasValue() or (children().count() > id.count())" />
2076         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
2077       </constraint>
2078       <constraint>
2079         <key value="ext-1" />
2080         <severity value="error" />
2081         <human value="Must have either extensions or value[x], not both" />
2082         <expression value="extension.exists() != value.exists()" />
2083         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
2084       </constraint>
2085       <isModifier value="false" />
2086       <isSummary value="false" />
2087       <mapping>
2088         <identity value="rim" />
2089         <map value="n/a" />
2090       </mapping>
2091     </element>
2092     <element id="DeviceDefinition.classification:gmdn.type.coding">
2093       <path value="DeviceDefinition.classification.type.coding" />
2094       <short value="Code defined by a terminology system" />
2095       <definition value="A reference to a code defined by a terminology system." />
2096       <comment value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true." />
2097       <requirements value="Allows for alternative encodings within a code system, and translations to other code systems." />
2098       <min value="0" />
2099       <max value="*" />
2100       <base>
2101         <path value="CodeableConcept.coding" />
2102         <min value="0" />
2103         <max value="*" />
2104       </base>
2105       <type>
2106         <code value="Coding" />
2107       </type>
2108       <constraint>
2109         <key value="ele-1" />
2110         <severity value="error" />
2111         <human value="All FHIR elements must have a @value or children" />
2112         <expression value="hasValue() or (children().count() > id.count())" />
2113         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
2114       </constraint>
2115       <isModifier value="false" />
2116       <isSummary value="true" />
2117       <mapping>
2118         <identity value="v2" />
2119         <map value="C*E.1-8, C*E.10-22" />
2120       </mapping>
2121       <mapping>
2122         <identity value="rim" />
2123         <map value="union(., ./translation)" />
2124       </mapping>
2125       <mapping>
2126         <identity value="orim" />
2127         <map value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding" />
2128       </mapping>
2129     </element>
2130     <element id="DeviceDefinition.classification:gmdn.type.coding.id">
2131       <path value="DeviceDefinition.classification.type.coding.id" />
2132       <representation value="xmlAttr" />
2133       <short value="Unique id for inter-element referencing" />
2134       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
2135       <min value="0" />
2136       <max value="1" />
2137       <base>
2138         <path value="Element.id" />
2139         <min value="0" />
2140         <max value="1" />
2141       </base>
2142       <type>
2143         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
2144           <valueUrl value="id" />
2145         </extension>
2146         <code value="http://hl7.org/fhirpath/System.String" />
2147       </type>
2148       <condition value="ele-1" />
2149       <isModifier value="false" />
2150       <isSummary value="false" />
2151       <mapping>
2152         <identity value="rim" />
2153         <map value="n/a" />
2154       </mapping>
2155     </element>
2156     <element id="DeviceDefinition.classification:gmdn.type.coding.extension">
2157       <path value="DeviceDefinition.classification.type.coding.extension" />
2158       <slicing>
2159         <discriminator>
2160           <type value="value" />
2161           <path value="url" />
2162         </discriminator>
2163         <description value="Extensions are always sliced by (at least) url" />
2164         <rules value="open" />
2165       </slicing>
2166       <short value="Additional content defined by implementations" />
2167       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
2168       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
2169       <alias value="extensions" />
2170       <alias value="user content" />
2171       <min value="0" />
2172       <max value="*" />
2173       <base>
2174         <path value="Element.extension" />
2175         <min value="0" />
2176         <max value="*" />
2177       </base>
2178       <type>
2179         <code value="Extension" />
2180       </type>
2181       <constraint>
2182         <key value="ele-1" />
2183         <severity value="error" />
2184         <human value="All FHIR elements must have a @value or children" />
2185         <expression value="hasValue() or (children().count() > id.count())" />
2186         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
2187       </constraint>
2188       <constraint>
2189         <key value="ext-1" />
2190         <severity value="error" />
2191         <human value="Must have either extensions or value[x], not both" />
2192         <expression value="extension.exists() != value.exists()" />
2193         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
2194       </constraint>
2195       <isModifier value="false" />
2196       <isSummary value="false" />
2197       <mapping>
2198         <identity value="rim" />
2199         <map value="n/a" />
2200       </mapping>
2201     </element>
2202     <element id="DeviceDefinition.classification:gmdn.type.coding.system">
2203       <path value="DeviceDefinition.classification.type.coding.system" />
2204       <short value="Identity of the terminology system" />
2205       <definition value="The identification of the code system that defines the meaning of the symbol in the code." />
2206       <comment value="The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...).  OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously." />
2207       <requirements value="Need to be unambiguous about the source of the definition of the symbol." />
2208       <min value="1" />
2209       <max value="1" />
2210       <base>
2211         <path value="Coding.system" />
2212         <min value="0" />
2213         <max value="1" />
2214       </base>
2215       <type>
2216         <code value="uri" />
2217       </type>
2218       <patternUri value="http://terminology.hl7.org/CodeSystem/GMDN" />
2219       <constraint>
2220         <key value="ele-1" />
2221         <severity value="error" />
2222         <human value="All FHIR elements must have a @value or children" />
2223         <expression value="hasValue() or (children().count() > id.count())" />
2224         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
2225       </constraint>
2226       <isModifier value="false" />
2227       <isSummary value="true" />
2228       <mapping>
2229         <identity value="devicedefinition-to-gudid" />
2230         <map value="http://terminology.hl7.org/CodeSystem/GMDN" />
2231       </mapping>
2232       <mapping>
2233         <identity value="v2" />
2234         <map value="C*E.3" />
2235       </mapping>
2236       <mapping>
2237         <identity value="rim" />
2238         <map value="./codeSystem" />
2239       </mapping>
2240       <mapping>
2241         <identity value="orim" />
2242         <map value="fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem" />
2243       </mapping>
2244     </element>
2245     <element id="DeviceDefinition.classification:gmdn.type.coding.version">
2246       <path value="DeviceDefinition.classification.type.coding.version" />
2247       <short value="Version of the system - if relevant" />
2248       <definition value="The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged." />
2249       <comment value="Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date." />
2250       <min value="0" />
2251       <max value="1" />
2252       <base>
2253         <path value="Coding.version" />
2254         <min value="0" />
2255         <max value="1" />
2256       </base>
2257       <type>
2258         <code value="string" />
2259       </type>
2260       <constraint>
2261         <key value="ele-1" />
2262         <severity value="error" />
2263         <human value="All FHIR elements must have a @value or children" />
2264         <expression value="hasValue() or (children().count() > id.count())" />
2265         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
2266       </constraint>
2267       <isModifier value="false" />
2268       <isSummary value="true" />
2269       <mapping>
2270         <identity value="v2" />
2271         <map value="C*E.7" />
2272       </mapping>
2273       <mapping>
2274         <identity value="rim" />
2275         <map value="./codeSystemVersion" />
2276       </mapping>
2277       <mapping>
2278         <identity value="orim" />
2279         <map value="fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion" />
2280       </mapping>
2281     </element>
2282     <element id="DeviceDefinition.classification:gmdn.type.coding.code">
2283       <path value="DeviceDefinition.classification.type.coding.code" />
2284       <short value="Symbol in syntax defined by the system" />
2285       <definition value="A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination)." />
2286       <requirements value="Need to refer to a particular code in the system." />
2287       <min value="0" />
2288       <max value="1" />
2289       <base>
2290         <path value="Coding.code" />
2291         <min value="0" />
2292         <max value="1" />
2293       </base>
2294       <type>
2295         <code value="code" />
2296       </type>
2297       <condition value="cod-1" />
2298       <constraint>
2299         <key value="ele-1" />
2300         <severity value="error" />
2301         <human value="All FHIR elements must have a @value or children" />
2302         <expression value="hasValue() or (children().count() > id.count())" />
2303         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
2304       </constraint>
2305       <isModifier value="false" />
2306       <isSummary value="true" />
2307       <mapping>
2308         <identity value="devicedefinition-to-gudid" />
2309         <map value="[GMDN code]" />
2310       </mapping>
2311       <mapping>
2312         <identity value="v2" />
2313         <map value="C*E.1" />
2314       </mapping>
2315       <mapping>
2316         <identity value="rim" />
2317         <map value="./code" />
2318       </mapping>
2319       <mapping>
2320         <identity value="orim" />
2321         <map value="fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code" />
2322       </mapping>
2323     </element>
2324     <element id="DeviceDefinition.classification:gmdn.type.coding.display">
2325       <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
2326         <valueBoolean value="true" />
2327       </extension>
2328       <path value="DeviceDefinition.classification.type.coding.display" />
2329       <short value="Representation defined by the system" />
2330       <definition value="A representation of the meaning of the code in the system, following the rules of the system." />
2331       <requirements value="Need to be able to carry a human-readable meaning of the code for readers that do not know  the system." />
2332       <min value="0" />
2333       <max value="1" />
2334       <base>
2335         <path value="Coding.display" />
2336         <min value="0" />
2337         <max value="1" />
2338       </base>
2339       <type>
2340         <code value="string" />
2341       </type>
2342       <condition value="cod-1" />
2343       <constraint>
2344         <key value="ele-1" />
2345         <severity value="error" />
2346         <human value="All FHIR elements must have a @value or children" />
2347         <expression value="hasValue() or (children().count() > id.count())" />
2348         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
2349       </constraint>
2350       <isModifier value="false" />
2351       <isSummary value="true" />
2352       <mapping>
2353         <identity value="devicedefinition-to-gudid" />
2354         <map value="GMDN Preferred Term Name" />
2355       </mapping>
2356       <mapping>
2357         <identity value="v2" />
2358         <map value="C*E.2 - but note this is not well followed" />
2359       </mapping>
2360       <mapping>
2361         <identity value="rim" />
2362         <map value="CV.displayName" />
2363       </mapping>
2364       <mapping>
2365         <identity value="orim" />
2366         <map value="fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName" />
2367       </mapping>
2368     </element>
2369     <element id="DeviceDefinition.classification:gmdn.type.coding.userSelected">
2370       <path value="DeviceDefinition.classification.type.coding.userSelected" />
2371       <short value="If this coding was chosen directly by the user" />
2372       <definition value="Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays)." />
2373       <comment value="Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely." />
2374       <requirements value="This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing." />
2375       <min value="0" />
2376       <max value="1" />
2377       <base>
2378         <path value="Coding.userSelected" />
2379         <min value="0" />
2380         <max value="1" />
2381       </base>
2382       <type>
2383         <code value="boolean" />
2384       </type>
2385       <constraint>
2386         <key value="ele-1" />
2387         <severity value="error" />
2388         <human value="All FHIR elements must have a @value or children" />
2389         <expression value="hasValue() or (children().count() > id.count())" />
2390         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
2391       </constraint>
2392       <isModifier value="false" />
2393       <isSummary value="true" />
2394       <mapping>
2395         <identity value="v2" />
2396         <map value="Sometimes implied by being first" />
2397       </mapping>
2398       <mapping>
2399         <identity value="rim" />
2400         <map value="CD.codingRationale" />
2401       </mapping>
2402       <mapping>
2403         <identity value="orim" />
2404         <map value="fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map;   fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [     fhir:source "true";     fhir:target dt:CDCoding.codingRationale\#O   ]" />
2405       </mapping>
2406     </element>
2407     <element id="DeviceDefinition.classification:gmdn.type.text">
2408       <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
2409         <valueBoolean value="true" />
2410       </extension>
2411       <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
2412         <valueBoolean value="true" />
2413       </extension>
2414       <path value="DeviceDefinition.classification.type.text" />
2415       <short value="Plain text representation of the concept" />
2416       <definition value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user." />
2417       <comment value="Very often the text is the same as a displayName of one of the codings." />
2418       <requirements value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source." />
2419       <min value="0" />
2420       <max value="1" />
2421       <base>
2422         <path value="CodeableConcept.text" />
2423         <min value="0" />
2424         <max value="1" />
2425       </base>
2426       <type>
2427         <code value="string" />
2428       </type>
2429       <constraint>
2430         <key value="ele-1" />
2431         <severity value="error" />
2432         <human value="All FHIR elements must have a @value or children" />
2433         <expression value="hasValue() or (children().count() > id.count())" />
2434         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
2435       </constraint>
2436       <isModifier value="false" />
2437       <isSummary value="true" />
2438       <mapping>
2439         <identity value="v2" />
2440         <map value="C*E.9. But note many systems use C*E.2 for this" />
2441       </mapping>
2442       <mapping>
2443         <identity value="rim" />
2444         <map value="./originalText[mediaType/code="text/plain"]/data" />
2445       </mapping>
2446       <mapping>
2447         <identity value="orim" />
2448         <map value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText" />
2449       </mapping>
2450     </element>
2451     <element id="DeviceDefinition.classification:gmdn.justification">
2452       <path value="DeviceDefinition.classification.justification" />
2453       <short value="Further information qualifying this classification of the device model" />
2454       <definition value="Further information qualifying this classification of the device model." />
2455       <min value="0" />
2456       <max value="*" />
2457       <base>
2458         <path value="DeviceDefinition.classification.justification" />
2459         <min value="0" />
2460         <max value="*" />
2461       </base>
2462       <type>
2463         <code value="RelatedArtifact" />
2464       </type>
2465       <constraint>
2466         <key value="ele-1" />
2467         <severity value="error" />
2468         <human value="All FHIR elements must have a @value or children" />
2469         <expression value="hasValue() or (children().count() > id.count())" />
2470         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
2471       </constraint>
2472       <mustSupport value="false" />
2473       <isModifier value="false" />
2474       <isSummary value="false" />
2475     </element>
2476     <element id="DeviceDefinition.classification:snomed">
2477       <path value="DeviceDefinition.classification" />
2478       <sliceName value="snomed" />
2479       <short value="SNOMED CT" />
2480       <definition value="Systematized nomenclature of medicine - clinical terms" />
2481       <comment value="In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes." />
2482       <min value="0" />
2483       <max value="1" />
2484       <base>
2485         <path value="DeviceDefinition.classification" />
2486         <min value="0" />
2487         <max value="*" />
2488       </base>
2489       <type>
2490         <code value="BackboneElement" />
2491       </type>
2492       <constraint>
2493         <key value="ele-1" />
2494         <severity value="error" />
2495         <human value="All FHIR elements must have a @value or children" />
2496         <expression value="hasValue() or (children().count() > id.count())" />
2497         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
2498       </constraint>
2499       <mustSupport value="false" />
2500       <isModifier value="false" />
2501       <isSummary value="true" />
2502     </element>
2503     <element id="DeviceDefinition.classification:snomed.id">
2504       <path value="DeviceDefinition.classification.id" />
2505       <representation value="xmlAttr" />
2506       <short value="Unique id for inter-element referencing" />
2507       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
2508       <min value="0" />
2509       <max value="1" />
2510       <base>
2511         <path value="Element.id" />
2512         <min value="0" />
2513         <max value="1" />
2514       </base>
2515       <type>
2516         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
2517           <valueUrl value="string" />
2518         </extension>
2519         <code value="http://hl7.org/fhirpath/System.String" />
2520       </type>
2521       <condition value="ele-1" />
2522       <isModifier value="false" />
2523       <isSummary value="false" />
2524       <mapping>
2525         <identity value="rim" />
2526         <map value="n/a" />
2527       </mapping>
2528     </element>
2529     <element id="DeviceDefinition.classification:snomed.extension">
2530       <path value="DeviceDefinition.classification.extension" />
2531       <short value="Additional content defined by implementations" />
2532       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
2533       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
2534       <alias value="extensions" />
2535       <alias value="user content" />
2536       <min value="0" />
2537       <max value="*" />
2538       <base>
2539         <path value="Element.extension" />
2540         <min value="0" />
2541         <max value="*" />
2542       </base>
2543       <type>
2544         <code value="Extension" />
2545       </type>
2546       <constraint>
2547         <key value="ele-1" />
2548         <severity value="error" />
2549         <human value="All FHIR elements must have a @value or children" />
2550         <expression value="hasValue() or (children().count() > id.count())" />
2551         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
2552       </constraint>
2553       <constraint>
2554         <key value="ext-1" />
2555         <severity value="error" />
2556         <human value="Must have either extensions or value[x], not both" />
2557         <expression value="extension.exists() != value.exists()" />
2558         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
2559       </constraint>
2560       <isModifier value="false" />
2561       <isSummary value="false" />
2562       <mapping>
2563         <identity value="rim" />
2564         <map value="n/a" />
2565       </mapping>
2566     </element>
2567     <element id="DeviceDefinition.classification:snomed.modifierExtension">
2568       <path value="DeviceDefinition.classification.modifierExtension" />
2569       <short value="Extensions that cannot be ignored even if unrecognized" />
2570       <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
2571       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
2572       <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)." />
2573       <alias value="extensions" />
2574       <alias value="user content" />
2575       <alias value="modifiers" />
2576       <min value="0" />
2577       <max value="*" />
2578       <base>
2579         <path value="BackboneElement.modifierExtension" />
2580         <min value="0" />
2581         <max value="*" />
2582       </base>
2583       <type>
2584         <code value="Extension" />
2585       </type>
2586       <constraint>
2587         <key value="ele-1" />
2588         <severity value="error" />
2589         <human value="All FHIR elements must have a @value or children" />
2590         <expression value="hasValue() or (children().count() > id.count())" />
2591         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
2592       </constraint>
2593       <constraint>
2594         <key value="ext-1" />
2595         <severity value="error" />
2596         <human value="Must have either extensions or value[x], not both" />
2597         <expression value="extension.exists() != value.exists()" />
2598         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
2599       </constraint>
2600       <isModifier value="true" />
2601       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
2602       <isSummary value="true" />
2603       <mapping>
2604         <identity value="rim" />
2605         <map value="N/A" />
2606       </mapping>
2607     </element>
2608     <element id="DeviceDefinition.classification:snomed.type">
2609       <path value="DeviceDefinition.classification.type" />
2610       <short value="A classification or risk class of the device model" />
2611       <definition value="A classification or risk class of the device model." />
2612       <min value="1" />
2613       <max value="1" />
2614       <base>
2615         <path value="DeviceDefinition.classification.type" />
2616         <min value="1" />
2617         <max value="1" />
2618       </base>
2619       <type>
2620         <code value="CodeableConcept" />
2621       </type>
2622       <constraint>
2623         <key value="ele-1" />
2624         <severity value="error" />
2625         <human value="All FHIR elements must have a @value or children" />
2626         <expression value="hasValue() or (children().count() > id.count())" />
2627         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
2628       </constraint>
2629       <mustSupport value="false" />
2630       <isModifier value="false" />
2631       <isSummary value="true" />
2632       <binding>
2633         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
2634           <valueString value="DeviceKind" />
2635         </extension>
2636         <strength value="example" />
2637         <description value="Type of device e.g. according to official classification." />
2638         <valueSet value="http://hl7.org/fhir/ValueSet/device-type" />
2639       </binding>
2640     </element>
2641     <element id="DeviceDefinition.classification:snomed.type.id">
2642       <path value="DeviceDefinition.classification.type.id" />
2643       <representation value="xmlAttr" />
2644       <short value="Unique id for inter-element referencing" />
2645       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
2646       <min value="0" />
2647       <max value="1" />
2648       <base>
2649         <path value="Element.id" />
2650         <min value="0" />
2651         <max value="1" />
2652       </base>
2653       <type>
2654         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
2655           <valueUrl value="id" />
2656         </extension>
2657         <code value="http://hl7.org/fhirpath/System.String" />
2658       </type>
2659       <condition value="ele-1" />
2660       <isModifier value="false" />
2661       <isSummary value="false" />
2662       <mapping>
2663         <identity value="rim" />
2664         <map value="n/a" />
2665       </mapping>
2666     </element>
2667     <element id="DeviceDefinition.classification:snomed.type.extension">
2668       <path value="DeviceDefinition.classification.type.extension" />
2669       <slicing>
2670         <discriminator>
2671           <type value="value" />
2672           <path value="url" />
2673         </discriminator>
2674         <description value="Extensions are always sliced by (at least) url" />
2675         <rules value="open" />
2676       </slicing>
2677       <short value="Additional content defined by implementations" />
2678       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
2679       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
2680       <alias value="extensions" />
2681       <alias value="user content" />
2682       <min value="0" />
2683       <max value="*" />
2684       <base>
2685         <path value="Element.extension" />
2686         <min value="0" />
2687         <max value="*" />
2688       </base>
2689       <type>
2690         <code value="Extension" />
2691       </type>
2692       <constraint>
2693         <key value="ele-1" />
2694         <severity value="error" />
2695         <human value="All FHIR elements must have a @value or children" />
2696         <expression value="hasValue() or (children().count() > id.count())" />
2697         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
2698       </constraint>
2699       <constraint>
2700         <key value="ext-1" />
2701         <severity value="error" />
2702         <human value="Must have either extensions or value[x], not both" />
2703         <expression value="extension.exists() != value.exists()" />
2704         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
2705       </constraint>
2706       <isModifier value="false" />
2707       <isSummary value="false" />
2708       <mapping>
2709         <identity value="rim" />
2710         <map value="n/a" />
2711       </mapping>
2712     </element>
2713     <element id="DeviceDefinition.classification:snomed.type.coding">
2714       <path value="DeviceDefinition.classification.type.coding" />
2715       <short value="Code defined by a terminology system" />
2716       <definition value="A reference to a code defined by a terminology system." />
2717       <comment value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true." />
2718       <requirements value="Allows for alternative encodings within a code system, and translations to other code systems." />
2719       <min value="0" />
2720       <max value="*" />
2721       <base>
2722         <path value="CodeableConcept.coding" />
2723         <min value="0" />
2724         <max value="*" />
2725       </base>
2726       <type>
2727         <code value="Coding" />
2728       </type>
2729       <constraint>
2730         <key value="ele-1" />
2731         <severity value="error" />
2732         <human value="All FHIR elements must have a @value or children" />
2733         <expression value="hasValue() or (children().count() > id.count())" />
2734         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
2735       </constraint>
2736       <isModifier value="false" />
2737       <isSummary value="true" />
2738       <mapping>
2739         <identity value="v2" />
2740         <map value="C*E.1-8, C*E.10-22" />
2741       </mapping>
2742       <mapping>
2743         <identity value="rim" />
2744         <map value="union(., ./translation)" />
2745       </mapping>
2746       <mapping>
2747         <identity value="orim" />
2748         <map value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding" />
2749       </mapping>
2750     </element>
2751     <element id="DeviceDefinition.classification:snomed.type.coding.id">
2752       <path value="DeviceDefinition.classification.type.coding.id" />
2753       <representation value="xmlAttr" />
2754       <short value="Unique id for inter-element referencing" />
2755       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
2756       <min value="0" />
2757       <max value="1" />
2758       <base>
2759         <path value="Element.id" />
2760         <min value="0" />
2761         <max value="1" />
2762       </base>
2763       <type>
2764         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
2765           <valueUrl value="id" />
2766         </extension>
2767         <code value="http://hl7.org/fhirpath/System.String" />
2768       </type>
2769       <condition value="ele-1" />
2770       <isModifier value="false" />
2771       <isSummary value="false" />
2772       <mapping>
2773         <identity value="rim" />
2774         <map value="n/a" />
2775       </mapping>
2776     </element>
2777     <element id="DeviceDefinition.classification:snomed.type.coding.extension">
2778       <path value="DeviceDefinition.classification.type.coding.extension" />
2779       <slicing>
2780         <discriminator>
2781           <type value="value" />
2782           <path value="url" />
2783         </discriminator>
2784         <description value="Extensions are always sliced by (at least) url" />
2785         <rules value="open" />
2786       </slicing>
2787       <short value="Additional content defined by implementations" />
2788       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
2789       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
2790       <alias value="extensions" />
2791       <alias value="user content" />
2792       <min value="0" />
2793       <max value="*" />
2794       <base>
2795         <path value="Element.extension" />
2796         <min value="0" />
2797         <max value="*" />
2798       </base>
2799       <type>
2800         <code value="Extension" />
2801       </type>
2802       <constraint>
2803         <key value="ele-1" />
2804         <severity value="error" />
2805         <human value="All FHIR elements must have a @value or children" />
2806         <expression value="hasValue() or (children().count() > id.count())" />
2807         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
2808       </constraint>
2809       <constraint>
2810         <key value="ext-1" />
2811         <severity value="error" />
2812         <human value="Must have either extensions or value[x], not both" />
2813         <expression value="extension.exists() != value.exists()" />
2814         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
2815       </constraint>
2816       <isModifier value="false" />
2817       <isSummary value="false" />
2818       <mapping>
2819         <identity value="rim" />
2820         <map value="n/a" />
2821       </mapping>
2822     </element>
2823     <element id="DeviceDefinition.classification:snomed.type.coding.system">
2824       <path value="DeviceDefinition.classification.type.coding.system" />
2825       <short value="Identity of the terminology system" />
2826       <definition value="The identification of the code system that defines the meaning of the symbol in the code." />
2827       <comment value="The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...).  OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously." />
2828       <requirements value="Need to be unambiguous about the source of the definition of the symbol." />
2829       <min value="1" />
2830       <max value="1" />
2831       <base>
2832         <path value="Coding.system" />
2833         <min value="0" />
2834         <max value="1" />
2835       </base>
2836       <type>
2837         <code value="uri" />
2838       </type>
2839       <patternUri value="http://snomed.info/sct" />
2840       <constraint>
2841         <key value="ele-1" />
2842         <severity value="error" />
2843         <human value="All FHIR elements must have a @value or children" />
2844         <expression value="hasValue() or (children().count() > id.count())" />
2845         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
2846       </constraint>
2847       <isModifier value="false" />
2848       <isSummary value="true" />
2849       <mapping>
2850         <identity value="v2" />
2851         <map value="C*E.3" />
2852       </mapping>
2853       <mapping>
2854         <identity value="rim" />
2855         <map value="./codeSystem" />
2856       </mapping>
2857       <mapping>
2858         <identity value="orim" />
2859         <map value="fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem" />
2860       </mapping>
2861     </element>
2862     <element id="DeviceDefinition.classification:snomed.type.coding.version">
2863       <path value="DeviceDefinition.classification.type.coding.version" />
2864       <short value="Version of the system - if relevant" />
2865       <definition value="The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged." />
2866       <comment value="Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date." />
2867       <min value="0" />
2868       <max value="1" />
2869       <base>
2870         <path value="Coding.version" />
2871         <min value="0" />
2872         <max value="1" />
2873       </base>
2874       <type>
2875         <code value="string" />
2876       </type>
2877       <constraint>
2878         <key value="ele-1" />
2879         <severity value="error" />
2880         <human value="All FHIR elements must have a @value or children" />
2881         <expression value="hasValue() or (children().count() > id.count())" />
2882         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
2883       </constraint>
2884       <isModifier value="false" />
2885       <isSummary value="true" />
2886       <mapping>
2887         <identity value="v2" />
2888         <map value="C*E.7" />
2889       </mapping>
2890       <mapping>
2891         <identity value="rim" />
2892         <map value="./codeSystemVersion" />
2893       </mapping>
2894       <mapping>
2895         <identity value="orim" />
2896         <map value="fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion" />
2897       </mapping>
2898     </element>
2899     <element id="DeviceDefinition.classification:snomed.type.coding.code">
2900       <path value="DeviceDefinition.classification.type.coding.code" />
2901       <short value="Symbol in syntax defined by the system" />
2902       <definition value="A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination)." />
2903       <requirements value="Need to refer to a particular code in the system." />
2904       <min value="0" />
2905       <max value="1" />
2906       <base>
2907         <path value="Coding.code" />
2908         <min value="0" />
2909         <max value="1" />
2910       </base>
2911       <type>
2912         <code value="code" />
2913       </type>
2914       <condition value="cod-1" />
2915       <constraint>
2916         <key value="ele-1" />
2917         <severity value="error" />
2918         <human value="All FHIR elements must have a @value or children" />
2919         <expression value="hasValue() or (children().count() > id.count())" />
2920         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
2921       </constraint>
2922       <isModifier value="false" />
2923       <isSummary value="true" />
2924       <mapping>
2925         <identity value="v2" />
2926         <map value="C*E.1" />
2927       </mapping>
2928       <mapping>
2929         <identity value="rim" />
2930         <map value="./code" />
2931       </mapping>
2932       <mapping>
2933         <identity value="orim" />
2934         <map value="fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code" />
2935       </mapping>
2936     </element>
2937     <element id="DeviceDefinition.classification:snomed.type.coding.display">
2938       <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
2939         <valueBoolean value="true" />
2940       </extension>
2941       <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
2942         <valueBoolean value="true" />
2943       </extension>
2944       <path value="DeviceDefinition.classification.type.coding.display" />
2945       <short value="Representation defined by the system" />
2946       <definition value="A representation of the meaning of the code in the system, following the rules of the system." />
2947       <requirements value="Need to be able to carry a human-readable meaning of the code for readers that do not know  the system." />
2948       <min value="0" />
2949       <max value="1" />
2950       <base>
2951         <path value="Coding.display" />
2952         <min value="0" />
2953         <max value="1" />
2954       </base>
2955       <type>
2956         <code value="string" />
2957       </type>
2958       <condition value="cod-1" />
2959       <constraint>
2960         <key value="ele-1" />
2961         <severity value="error" />
2962         <human value="All FHIR elements must have a @value or children" />
2963         <expression value="hasValue() or (children().count() > id.count())" />
2964         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
2965       </constraint>
2966       <isModifier value="false" />
2967       <isSummary value="true" />
2968       <mapping>
2969         <identity value="v2" />
2970         <map value="C*E.2 - but note this is not well followed" />
2971       </mapping>
2972       <mapping>
2973         <identity value="rim" />
2974         <map value="CV.displayName" />
2975       </mapping>
2976       <mapping>
2977         <identity value="orim" />
2978         <map value="fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName" />
2979       </mapping>
2980     </element>
2981     <element id="DeviceDefinition.classification:snomed.type.coding.userSelected">
2982       <path value="DeviceDefinition.classification.type.coding.userSelected" />
2983       <short value="If this coding was chosen directly by the user" />
2984       <definition value="Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays)." />
2985       <comment value="Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely." />
2986       <requirements value="This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing." />
2987       <min value="0" />
2988       <max value="1" />
2989       <base>
2990         <path value="Coding.userSelected" />
2991         <min value="0" />
2992         <max value="1" />
2993       </base>
2994       <type>
2995         <code value="boolean" />
2996       </type>
2997       <constraint>
2998         <key value="ele-1" />
2999         <severity value="error" />
3000         <human value="All FHIR elements must have a @value or children" />
3001         <expression value="hasValue() or (children().count() > id.count())" />
3002         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3003       </constraint>
3004       <isModifier value="false" />
3005       <isSummary value="true" />
3006       <mapping>
3007         <identity value="v2" />
3008         <map value="Sometimes implied by being first" />
3009       </mapping>
3010       <mapping>
3011         <identity value="rim" />
3012         <map value="CD.codingRationale" />
3013       </mapping>
3014       <mapping>
3015         <identity value="orim" />
3016         <map value="fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map;   fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [     fhir:source "true";     fhir:target dt:CDCoding.codingRationale\#O   ]" />
3017       </mapping>
3018     </element>
3019     <element id="DeviceDefinition.classification:snomed.type.text">
3020       <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
3021         <valueBoolean value="true" />
3022       </extension>
3023       <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
3024         <valueBoolean value="true" />
3025       </extension>
3026       <path value="DeviceDefinition.classification.type.text" />
3027       <short value="Plain text representation of the concept" />
3028       <definition value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user." />
3029       <comment value="Very often the text is the same as a displayName of one of the codings." />
3030       <requirements value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source." />
3031       <min value="0" />
3032       <max value="1" />
3033       <base>
3034         <path value="CodeableConcept.text" />
3035         <min value="0" />
3036         <max value="1" />
3037       </base>
3038       <type>
3039         <code value="string" />
3040       </type>
3041       <constraint>
3042         <key value="ele-1" />
3043         <severity value="error" />
3044         <human value="All FHIR elements must have a @value or children" />
3045         <expression value="hasValue() or (children().count() > id.count())" />
3046         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3047       </constraint>
3048       <isModifier value="false" />
3049       <isSummary value="true" />
3050       <mapping>
3051         <identity value="v2" />
3052         <map value="C*E.9. But note many systems use C*E.2 for this" />
3053       </mapping>
3054       <mapping>
3055         <identity value="rim" />
3056         <map value="./originalText[mediaType/code="text/plain"]/data" />
3057       </mapping>
3058       <mapping>
3059         <identity value="orim" />
3060         <map value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText" />
3061       </mapping>
3062     </element>
3063     <element id="DeviceDefinition.classification:snomed.justification">
3064       <path value="DeviceDefinition.classification.justification" />
3065       <short value="Further information qualifying this classification of the device model" />
3066       <definition value="Further information qualifying this classification of the device model." />
3067       <min value="0" />
3068       <max value="*" />
3069       <base>
3070         <path value="DeviceDefinition.classification.justification" />
3071         <min value="0" />
3072         <max value="*" />
3073       </base>
3074       <type>
3075         <code value="RelatedArtifact" />
3076       </type>
3077       <constraint>
3078         <key value="ele-1" />
3079         <severity value="error" />
3080         <human value="All FHIR elements must have a @value or children" />
3081         <expression value="hasValue() or (children().count() > id.count())" />
3082         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3083       </constraint>
3084       <mustSupport value="false" />
3085       <isModifier value="false" />
3086       <isSummary value="false" />
3087     </element>
3088     <element id="DeviceDefinition.classification:emdn">
3089       <path value="DeviceDefinition.classification" />
3090       <sliceName value="emdn" />
3091       <short value="EMDN" />
3092       <definition value="European Medical Device Nomenclature" />
3093       <comment value="In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes." />
3094       <min value="0" />
3095       <max value="1" />
3096       <base>
3097         <path value="DeviceDefinition.classification" />
3098         <min value="0" />
3099         <max value="*" />
3100       </base>
3101       <type>
3102         <code value="BackboneElement" />
3103       </type>
3104       <constraint>
3105         <key value="ele-1" />
3106         <severity value="error" />
3107         <human value="All FHIR elements must have a @value or children" />
3108         <expression value="hasValue() or (children().count() > id.count())" />
3109         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3110       </constraint>
3111       <mustSupport value="false" />
3112       <isModifier value="false" />
3113       <isSummary value="true" />
3114     </element>
3115     <element id="DeviceDefinition.classification:emdn.id">
3116       <path value="DeviceDefinition.classification.id" />
3117       <representation value="xmlAttr" />
3118       <short value="Unique id for inter-element referencing" />
3119       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
3120       <min value="0" />
3121       <max value="1" />
3122       <base>
3123         <path value="Element.id" />
3124         <min value="0" />
3125         <max value="1" />
3126       </base>
3127       <type>
3128         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
3129           <valueUrl value="string" />
3130         </extension>
3131         <code value="http://hl7.org/fhirpath/System.String" />
3132       </type>
3133       <condition value="ele-1" />
3134       <isModifier value="false" />
3135       <isSummary value="false" />
3136       <mapping>
3137         <identity value="rim" />
3138         <map value="n/a" />
3139       </mapping>
3140     </element>
3141     <element id="DeviceDefinition.classification:emdn.extension">
3142       <path value="DeviceDefinition.classification.extension" />
3143       <short value="Additional content defined by implementations" />
3144       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
3145       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
3146       <alias value="extensions" />
3147       <alias value="user content" />
3148       <min value="0" />
3149       <max value="*" />
3150       <base>
3151         <path value="Element.extension" />
3152         <min value="0" />
3153         <max value="*" />
3154       </base>
3155       <type>
3156         <code value="Extension" />
3157       </type>
3158       <constraint>
3159         <key value="ele-1" />
3160         <severity value="error" />
3161         <human value="All FHIR elements must have a @value or children" />
3162         <expression value="hasValue() or (children().count() > id.count())" />
3163         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3164       </constraint>
3165       <constraint>
3166         <key value="ext-1" />
3167         <severity value="error" />
3168         <human value="Must have either extensions or value[x], not both" />
3169         <expression value="extension.exists() != value.exists()" />
3170         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
3171       </constraint>
3172       <isModifier value="false" />
3173       <isSummary value="false" />
3174       <mapping>
3175         <identity value="rim" />
3176         <map value="n/a" />
3177       </mapping>
3178     </element>
3179     <element id="DeviceDefinition.classification:emdn.modifierExtension">
3180       <path value="DeviceDefinition.classification.modifierExtension" />
3181       <short value="Extensions that cannot be ignored even if unrecognized" />
3182       <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
3183       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
3184       <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)." />
3185       <alias value="extensions" />
3186       <alias value="user content" />
3187       <alias value="modifiers" />
3188       <min value="0" />
3189       <max value="*" />
3190       <base>
3191         <path value="BackboneElement.modifierExtension" />
3192         <min value="0" />
3193         <max value="*" />
3194       </base>
3195       <type>
3196         <code value="Extension" />
3197       </type>
3198       <constraint>
3199         <key value="ele-1" />
3200         <severity value="error" />
3201         <human value="All FHIR elements must have a @value or children" />
3202         <expression value="hasValue() or (children().count() > id.count())" />
3203         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3204       </constraint>
3205       <constraint>
3206         <key value="ext-1" />
3207         <severity value="error" />
3208         <human value="Must have either extensions or value[x], not both" />
3209         <expression value="extension.exists() != value.exists()" />
3210         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
3211       </constraint>
3212       <isModifier value="true" />
3213       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
3214       <isSummary value="true" />
3215       <mapping>
3216         <identity value="rim" />
3217         <map value="N/A" />
3218       </mapping>
3219     </element>
3220     <element id="DeviceDefinition.classification:emdn.type">
3221       <path value="DeviceDefinition.classification.type" />
3222       <short value="A classification or risk class of the device model" />
3223       <definition value="A classification or risk class of the device model." />
3224       <min value="1" />
3225       <max value="1" />
3226       <base>
3227         <path value="DeviceDefinition.classification.type" />
3228         <min value="1" />
3229         <max value="1" />
3230       </base>
3231       <type>
3232         <code value="CodeableConcept" />
3233       </type>
3234       <constraint>
3235         <key value="ele-1" />
3236         <severity value="error" />
3237         <human value="All FHIR elements must have a @value or children" />
3238         <expression value="hasValue() or (children().count() > id.count())" />
3239         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3240       </constraint>
3241       <mustSupport value="false" />
3242       <isModifier value="false" />
3243       <isSummary value="true" />
3244       <binding>
3245         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
3246           <valueString value="DeviceKind" />
3247         </extension>
3248         <strength value="example" />
3249         <description value="Type of device e.g. according to official classification." />
3250         <valueSet value="http://hl7.org/fhir/ValueSet/device-type" />
3251       </binding>
3252     </element>
3253     <element id="DeviceDefinition.classification:emdn.type.id">
3254       <path value="DeviceDefinition.classification.type.id" />
3255       <representation value="xmlAttr" />
3256       <short value="Unique id for inter-element referencing" />
3257       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
3258       <min value="0" />
3259       <max value="1" />
3260       <base>
3261         <path value="Element.id" />
3262         <min value="0" />
3263         <max value="1" />
3264       </base>
3265       <type>
3266         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
3267           <valueUrl value="id" />
3268         </extension>
3269         <code value="http://hl7.org/fhirpath/System.String" />
3270       </type>
3271       <condition value="ele-1" />
3272       <isModifier value="false" />
3273       <isSummary value="false" />
3274       <mapping>
3275         <identity value="rim" />
3276         <map value="n/a" />
3277       </mapping>
3278     </element>
3279     <element id="DeviceDefinition.classification:emdn.type.extension">
3280       <path value="DeviceDefinition.classification.type.extension" />
3281       <slicing>
3282         <discriminator>
3283           <type value="value" />
3284           <path value="url" />
3285         </discriminator>
3286         <description value="Extensions are always sliced by (at least) url" />
3287         <rules value="open" />
3288       </slicing>
3289       <short value="Additional content defined by implementations" />
3290       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
3291       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
3292       <alias value="extensions" />
3293       <alias value="user content" />
3294       <min value="0" />
3295       <max value="*" />
3296       <base>
3297         <path value="Element.extension" />
3298         <min value="0" />
3299         <max value="*" />
3300       </base>
3301       <type>
3302         <code value="Extension" />
3303       </type>
3304       <constraint>
3305         <key value="ele-1" />
3306         <severity value="error" />
3307         <human value="All FHIR elements must have a @value or children" />
3308         <expression value="hasValue() or (children().count() > id.count())" />
3309         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3310       </constraint>
3311       <constraint>
3312         <key value="ext-1" />
3313         <severity value="error" />
3314         <human value="Must have either extensions or value[x], not both" />
3315         <expression value="extension.exists() != value.exists()" />
3316         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
3317       </constraint>
3318       <isModifier value="false" />
3319       <isSummary value="false" />
3320       <mapping>
3321         <identity value="rim" />
3322         <map value="n/a" />
3323       </mapping>
3324     </element>
3325     <element id="DeviceDefinition.classification:emdn.type.coding">
3326       <path value="DeviceDefinition.classification.type.coding" />
3327       <short value="Code defined by a terminology system" />
3328       <definition value="A reference to a code defined by a terminology system." />
3329       <comment value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true." />
3330       <requirements value="Allows for alternative encodings within a code system, and translations to other code systems." />
3331       <min value="0" />
3332       <max value="*" />
3333       <base>
3334         <path value="CodeableConcept.coding" />
3335         <min value="0" />
3336         <max value="*" />
3337       </base>
3338       <type>
3339         <code value="Coding" />
3340       </type>
3341       <constraint>
3342         <key value="ele-1" />
3343         <severity value="error" />
3344         <human value="All FHIR elements must have a @value or children" />
3345         <expression value="hasValue() or (children().count() > id.count())" />
3346         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3347       </constraint>
3348       <isModifier value="false" />
3349       <isSummary value="true" />
3350       <mapping>
3351         <identity value="v2" />
3352         <map value="C*E.1-8, C*E.10-22" />
3353       </mapping>
3354       <mapping>
3355         <identity value="rim" />
3356         <map value="union(., ./translation)" />
3357       </mapping>
3358       <mapping>
3359         <identity value="orim" />
3360         <map value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding" />
3361       </mapping>
3362     </element>
3363     <element id="DeviceDefinition.classification:emdn.type.coding.id">
3364       <path value="DeviceDefinition.classification.type.coding.id" />
3365       <representation value="xmlAttr" />
3366       <short value="Unique id for inter-element referencing" />
3367       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
3368       <min value="0" />
3369       <max value="1" />
3370       <base>
3371         <path value="Element.id" />
3372         <min value="0" />
3373         <max value="1" />
3374       </base>
3375       <type>
3376         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
3377           <valueUrl value="id" />
3378         </extension>
3379         <code value="http://hl7.org/fhirpath/System.String" />
3380       </type>
3381       <condition value="ele-1" />
3382       <isModifier value="false" />
3383       <isSummary value="false" />
3384       <mapping>
3385         <identity value="rim" />
3386         <map value="n/a" />
3387       </mapping>
3388     </element>
3389     <element id="DeviceDefinition.classification:emdn.type.coding.extension">
3390       <path value="DeviceDefinition.classification.type.coding.extension" />
3391       <slicing>
3392         <discriminator>
3393           <type value="value" />
3394           <path value="url" />
3395         </discriminator>
3396         <description value="Extensions are always sliced by (at least) url" />
3397         <rules value="open" />
3398       </slicing>
3399       <short value="Additional content defined by implementations" />
3400       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
3401       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
3402       <alias value="extensions" />
3403       <alias value="user content" />
3404       <min value="0" />
3405       <max value="*" />
3406       <base>
3407         <path value="Element.extension" />
3408         <min value="0" />
3409         <max value="*" />
3410       </base>
3411       <type>
3412         <code value="Extension" />
3413       </type>
3414       <constraint>
3415         <key value="ele-1" />
3416         <severity value="error" />
3417         <human value="All FHIR elements must have a @value or children" />
3418         <expression value="hasValue() or (children().count() > id.count())" />
3419         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3420       </constraint>
3421       <constraint>
3422         <key value="ext-1" />
3423         <severity value="error" />
3424         <human value="Must have either extensions or value[x], not both" />
3425         <expression value="extension.exists() != value.exists()" />
3426         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
3427       </constraint>
3428       <isModifier value="false" />
3429       <isSummary value="false" />
3430       <mapping>
3431         <identity value="rim" />
3432         <map value="n/a" />
3433       </mapping>
3434     </element>
3435     <element id="DeviceDefinition.classification:emdn.type.coding.system">
3436       <path value="DeviceDefinition.classification.type.coding.system" />
3437       <short value="Identity of the terminology system" />
3438       <definition value="The identification of the code system that defines the meaning of the symbol in the code." />
3439       <comment value="The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...).  OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously." />
3440       <requirements value="Need to be unambiguous about the source of the definition of the symbol." />
3441       <min value="1" />
3442       <max value="1" />
3443       <base>
3444         <path value="Coding.system" />
3445         <min value="0" />
3446         <max value="1" />
3447       </base>
3448       <type>
3449         <code value="uri" />
3450       </type>
3451       <patternUri value="urn:oid:1.2.250.1.213.2.68" />
3452       <constraint>
3453         <key value="ele-1" />
3454         <severity value="error" />
3455         <human value="All FHIR elements must have a @value or children" />
3456         <expression value="hasValue() or (children().count() > id.count())" />
3457         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3458       </constraint>
3459       <isModifier value="false" />
3460       <isSummary value="true" />
3461       <mapping>
3462         <identity value="devicedefinition-to-eudamed" />
3463         <map value="urn:oid:1.2.250.1.213.2.68" />
3464       </mapping>
3465       <mapping>
3466         <identity value="v2" />
3467         <map value="C*E.3" />
3468       </mapping>
3469       <mapping>
3470         <identity value="rim" />
3471         <map value="./codeSystem" />
3472       </mapping>
3473       <mapping>
3474         <identity value="orim" />
3475         <map value="fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem" />
3476       </mapping>
3477     </element>
3478     <element id="DeviceDefinition.classification:emdn.type.coding.version">
3479       <path value="DeviceDefinition.classification.type.coding.version" />
3480       <short value="Version of the system - if relevant" />
3481       <definition value="The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged." />
3482       <comment value="Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date." />
3483       <min value="0" />
3484       <max value="1" />
3485       <base>
3486         <path value="Coding.version" />
3487         <min value="0" />
3488         <max value="1" />
3489       </base>
3490       <type>
3491         <code value="string" />
3492       </type>
3493       <constraint>
3494         <key value="ele-1" />
3495         <severity value="error" />
3496         <human value="All FHIR elements must have a @value or children" />
3497         <expression value="hasValue() or (children().count() > id.count())" />
3498         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3499       </constraint>
3500       <isModifier value="false" />
3501       <isSummary value="true" />
3502       <mapping>
3503         <identity value="v2" />
3504         <map value="C*E.7" />
3505       </mapping>
3506       <mapping>
3507         <identity value="rim" />
3508         <map value="./codeSystemVersion" />
3509       </mapping>
3510       <mapping>
3511         <identity value="orim" />
3512         <map value="fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion" />
3513       </mapping>
3514     </element>
3515     <element id="DeviceDefinition.classification:emdn.type.coding.code">
3516       <path value="DeviceDefinition.classification.type.coding.code" />
3517       <short value="Symbol in syntax defined by the system" />
3518       <definition value="A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination)." />
3519       <requirements value="Need to refer to a particular code in the system." />
3520       <min value="0" />
3521       <max value="1" />
3522       <base>
3523         <path value="Coding.code" />
3524         <min value="0" />
3525         <max value="1" />
3526       </base>
3527       <type>
3528         <code value="code" />
3529       </type>
3530       <condition value="cod-1" />
3531       <constraint>
3532         <key value="ele-1" />
3533         <severity value="error" />
3534         <human value="All FHIR elements must have a @value or children" />
3535         <expression value="hasValue() or (children().count() > id.count())" />
3536         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3537       </constraint>
3538       <isModifier value="false" />
3539       <isSummary value="true" />
3540       <mapping>
3541         <identity value="devicedefinition-to-eudamed" />
3542         <map value="[EMDN code]" />
3543       </mapping>
3544       <mapping>
3545         <identity value="v2" />
3546         <map value="C*E.1" />
3547       </mapping>
3548       <mapping>
3549         <identity value="rim" />
3550         <map value="./code" />
3551       </mapping>
3552       <mapping>
3553         <identity value="orim" />
3554         <map value="fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code" />
3555       </mapping>
3556     </element>
3557     <element id="DeviceDefinition.classification:emdn.type.coding.display">
3558       <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
3559         <valueBoolean value="true" />
3560       </extension>
3561       <path value="DeviceDefinition.classification.type.coding.display" />
3562       <short value="Representation defined by the system" />
3563       <definition value="A representation of the meaning of the code in the system, following the rules of the system." />
3564       <requirements value="Need to be able to carry a human-readable meaning of the code for readers that do not know  the system." />
3565       <min value="0" />
3566       <max value="1" />
3567       <base>
3568         <path value="Coding.display" />
3569         <min value="0" />
3570         <max value="1" />
3571       </base>
3572       <type>
3573         <code value="string" />
3574       </type>
3575       <condition value="cod-1" />
3576       <constraint>
3577         <key value="ele-1" />
3578         <severity value="error" />
3579         <human value="All FHIR elements must have a @value or children" />
3580         <expression value="hasValue() or (children().count() > id.count())" />
3581         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3582       </constraint>
3583       <isModifier value="false" />
3584       <isSummary value="true" />
3585       <mapping>
3586         <identity value="devicedefinition-to-eudamed" />
3587         <map value="EMDN name" />
3588       </mapping>
3589       <mapping>
3590         <identity value="v2" />
3591         <map value="C*E.2 - but note this is not well followed" />
3592       </mapping>
3593       <mapping>
3594         <identity value="rim" />
3595         <map value="CV.displayName" />
3596       </mapping>
3597       <mapping>
3598         <identity value="orim" />
3599         <map value="fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName" />
3600       </mapping>
3601     </element>
3602     <element id="DeviceDefinition.classification:emdn.type.coding.userSelected">
3603       <path value="DeviceDefinition.classification.type.coding.userSelected" />
3604       <short value="If this coding was chosen directly by the user" />
3605       <definition value="Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays)." />
3606       <comment value="Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely." />
3607       <requirements value="This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing." />
3608       <min value="0" />
3609       <max value="1" />
3610       <base>
3611         <path value="Coding.userSelected" />
3612         <min value="0" />
3613         <max value="1" />
3614       </base>
3615       <type>
3616         <code value="boolean" />
3617       </type>
3618       <constraint>
3619         <key value="ele-1" />
3620         <severity value="error" />
3621         <human value="All FHIR elements must have a @value or children" />
3622         <expression value="hasValue() or (children().count() > id.count())" />
3623         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3624       </constraint>
3625       <isModifier value="false" />
3626       <isSummary value="true" />
3627       <mapping>
3628         <identity value="v2" />
3629         <map value="Sometimes implied by being first" />
3630       </mapping>
3631       <mapping>
3632         <identity value="rim" />
3633         <map value="CD.codingRationale" />
3634       </mapping>
3635       <mapping>
3636         <identity value="orim" />
3637         <map value="fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map;   fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [     fhir:source "true";     fhir:target dt:CDCoding.codingRationale\#O   ]" />
3638       </mapping>
3639     </element>
3640     <element id="DeviceDefinition.classification:emdn.type.text">
3641       <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
3642         <valueBoolean value="true" />
3643       </extension>
3644       <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
3645         <valueBoolean value="true" />
3646       </extension>
3647       <path value="DeviceDefinition.classification.type.text" />
3648       <short value="Plain text representation of the concept" />
3649       <definition value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user." />
3650       <comment value="Very often the text is the same as a displayName of one of the codings." />
3651       <requirements value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source." />
3652       <min value="0" />
3653       <max value="1" />
3654       <base>
3655         <path value="CodeableConcept.text" />
3656         <min value="0" />
3657         <max value="1" />
3658       </base>
3659       <type>
3660         <code value="string" />
3661       </type>
3662       <constraint>
3663         <key value="ele-1" />
3664         <severity value="error" />
3665         <human value="All FHIR elements must have a @value or children" />
3666         <expression value="hasValue() or (children().count() > id.count())" />
3667         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3668       </constraint>
3669       <isModifier value="false" />
3670       <isSummary value="true" />
3671       <mapping>
3672         <identity value="v2" />
3673         <map value="C*E.9. But note many systems use C*E.2 for this" />
3674       </mapping>
3675       <mapping>
3676         <identity value="rim" />
3677         <map value="./originalText[mediaType/code="text/plain"]/data" />
3678       </mapping>
3679       <mapping>
3680         <identity value="orim" />
3681         <map value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText" />
3682       </mapping>
3683     </element>
3684     <element id="DeviceDefinition.classification:emdn.justification">
3685       <path value="DeviceDefinition.classification.justification" />
3686       <short value="Further information qualifying this classification of the device model" />
3687       <definition value="Further information qualifying this classification of the device model." />
3688       <min value="0" />
3689       <max value="*" />
3690       <base>
3691         <path value="DeviceDefinition.classification.justification" />
3692         <min value="0" />
3693         <max value="*" />
3694       </base>
3695       <type>
3696         <code value="RelatedArtifact" />
3697       </type>
3698       <constraint>
3699         <key value="ele-1" />
3700         <severity value="error" />
3701         <human value="All FHIR elements must have a @value or children" />
3702         <expression value="hasValue() or (children().count() > id.count())" />
3703         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3704       </constraint>
3705       <mustSupport value="false" />
3706       <isModifier value="false" />
3707       <isSummary value="false" />
3708     </element>
3709     <element id="DeviceDefinition.conformsTo">
3710       <path value="DeviceDefinition.conformsTo" />
3711       <short value="Identifies the standards, specifications, or formal guidances for the capabilities supported by the device" />
3712       <definition value="Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. The device may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standards." />
3713       <min value="0" />
3714       <max value="*" />
3715       <base>
3716         <path value="DeviceDefinition.conformsTo" />
3717         <min value="0" />
3718         <max value="*" />
3719       </base>
3720       <type>
3721         <code value="BackboneElement" />
3722       </type>
3723       <constraint>
3724         <key value="ele-1" />
3725         <severity value="error" />
3726         <human value="All FHIR elements must have a @value or children" />
3727         <expression value="hasValue() or (children().count() > id.count())" />
3728         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3729       </constraint>
3730       <mustSupport value="false" />
3731       <isModifier value="false" />
3732       <isSummary value="true" />
3733     </element>
3734     <element id="DeviceDefinition.conformsTo.id">
3735       <path value="DeviceDefinition.conformsTo.id" />
3736       <representation value="xmlAttr" />
3737       <short value="Unique id for inter-element referencing" />
3738       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
3739       <min value="0" />
3740       <max value="1" />
3741       <base>
3742         <path value="Element.id" />
3743         <min value="0" />
3744         <max value="1" />
3745       </base>
3746       <type>
3747         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
3748           <valueUrl value="string" />
3749         </extension>
3750         <code value="http://hl7.org/fhirpath/System.String" />
3751       </type>
3752       <condition value="ele-1" />
3753       <isModifier value="false" />
3754       <isSummary value="false" />
3755       <mapping>
3756         <identity value="rim" />
3757         <map value="n/a" />
3758       </mapping>
3759     </element>
3760     <element id="DeviceDefinition.conformsTo.extension">
3761       <path value="DeviceDefinition.conformsTo.extension" />
3762       <short value="Additional content defined by implementations" />
3763       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
3764       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
3765       <alias value="extensions" />
3766       <alias value="user content" />
3767       <min value="0" />
3768       <max value="*" />
3769       <base>
3770         <path value="Element.extension" />
3771         <min value="0" />
3772         <max value="*" />
3773       </base>
3774       <type>
3775         <code value="Extension" />
3776       </type>
3777       <constraint>
3778         <key value="ele-1" />
3779         <severity value="error" />
3780         <human value="All FHIR elements must have a @value or children" />
3781         <expression value="hasValue() or (children().count() > id.count())" />
3782         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3783       </constraint>
3784       <constraint>
3785         <key value="ext-1" />
3786         <severity value="error" />
3787         <human value="Must have either extensions or value[x], not both" />
3788         <expression value="extension.exists() != value.exists()" />
3789         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
3790       </constraint>
3791       <isModifier value="false" />
3792       <isSummary value="false" />
3793       <mapping>
3794         <identity value="rim" />
3795         <map value="n/a" />
3796       </mapping>
3797     </element>
3798     <element id="DeviceDefinition.conformsTo.modifierExtension">
3799       <path value="DeviceDefinition.conformsTo.modifierExtension" />
3800       <short value="Extensions that cannot be ignored even if unrecognized" />
3801       <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
3802       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
3803       <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)." />
3804       <alias value="extensions" />
3805       <alias value="user content" />
3806       <alias value="modifiers" />
3807       <min value="0" />
3808       <max value="*" />
3809       <base>
3810         <path value="BackboneElement.modifierExtension" />
3811         <min value="0" />
3812         <max value="*" />
3813       </base>
3814       <type>
3815         <code value="Extension" />
3816       </type>
3817       <constraint>
3818         <key value="ele-1" />
3819         <severity value="error" />
3820         <human value="All FHIR elements must have a @value or children" />
3821         <expression value="hasValue() or (children().count() > id.count())" />
3822         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3823       </constraint>
3824       <constraint>
3825         <key value="ext-1" />
3826         <severity value="error" />
3827         <human value="Must have either extensions or value[x], not both" />
3828         <expression value="extension.exists() != value.exists()" />
3829         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
3830       </constraint>
3831       <isModifier value="true" />
3832       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
3833       <isSummary value="true" />
3834       <mapping>
3835         <identity value="rim" />
3836         <map value="N/A" />
3837       </mapping>
3838     </element>
3839     <element id="DeviceDefinition.conformsTo.category">
3840       <path value="DeviceDefinition.conformsTo.category" />
3841       <short value="Describes the common type of the standard, specification, or formal guidance" />
3842       <definition value="Describes the type of the standard, specification, or formal guidance." />
3843       <min value="0" />
3844       <max value="1" />
3845       <base>
3846         <path value="DeviceDefinition.conformsTo.category" />
3847         <min value="0" />
3848         <max value="1" />
3849       </base>
3850       <type>
3851         <code value="CodeableConcept" />
3852       </type>
3853       <constraint>
3854         <key value="ele-1" />
3855         <severity value="error" />
3856         <human value="All FHIR elements must have a @value or children" />
3857         <expression value="hasValue() or (children().count() > id.count())" />
3858         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3859       </constraint>
3860       <mustSupport value="false" />
3861       <isModifier value="false" />
3862       <isSummary value="true" />
3863       <binding>
3864         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
3865           <valueString value="DeviceSpecificationCategory" />
3866         </extension>
3867         <strength value="example" />
3868         <valueSet value="http://hl7.org/fhir/ValueSet/device-specification-category" />
3869       </binding>
3870     </element>
3871     <element id="DeviceDefinition.conformsTo.specification">
3872       <path value="DeviceDefinition.conformsTo.specification" />
3873       <short value="Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type" />
3874       <definition value="Code that identifies the specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device adheres." />
3875       <min value="1" />
3876       <max value="1" />
3877       <base>
3878         <path value="DeviceDefinition.conformsTo.specification" />
3879         <min value="1" />
3880         <max value="1" />
3881       </base>
3882       <type>
3883         <code value="CodeableConcept" />
3884       </type>
3885       <constraint>
3886         <key value="ele-1" />
3887         <severity value="error" />
3888         <human value="All FHIR elements must have a @value or children" />
3889         <expression value="hasValue() or (children().count() > id.count())" />
3890         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3891       </constraint>
3892       <mustSupport value="false" />
3893       <isModifier value="false" />
3894       <isSummary value="true" />
3895       <binding>
3896         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
3897           <valueString value="DeviceSpecificationType" />
3898         </extension>
3899         <strength value="example" />
3900         <valueSet value="http://hl7.org/fhir/ValueSet/device-specification-type" />
3901       </binding>
3902     </element>
3903     <element id="DeviceDefinition.conformsTo.version">
3904       <path value="DeviceDefinition.conformsTo.version" />
3905       <short value="The specific form or variant of the standard, specification or formal guidance" />
3906       <definition value="Identifies the specific form or variant of the standard, specification, or formal guidance. This may be a 'version number', release, document edition, publication year, or other label." />
3907       <min value="0" />
3908       <max value="*" />
3909       <base>
3910         <path value="DeviceDefinition.conformsTo.version" />
3911         <min value="0" />
3912         <max value="*" />
3913       </base>
3914       <type>
3915         <code value="string" />
3916       </type>
3917       <constraint>
3918         <key value="ele-1" />
3919         <severity value="error" />
3920         <human value="All FHIR elements must have a @value or children" />
3921         <expression value="hasValue() or (children().count() > id.count())" />
3922         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3923       </constraint>
3924       <mustSupport value="false" />
3925       <isModifier value="false" />
3926       <isSummary value="true" />
3927     </element>
3928     <element id="DeviceDefinition.conformsTo.source">
3929       <path value="DeviceDefinition.conformsTo.source" />
3930       <short value="Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance" />
3931       <definition value="Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance." />
3932       <min value="0" />
3933       <max value="*" />
3934       <base>
3935         <path value="DeviceDefinition.conformsTo.source" />
3936         <min value="0" />
3937         <max value="*" />
3938       </base>
3939       <type>
3940         <code value="RelatedArtifact" />
3941       </type>
3942       <constraint>
3943         <key value="ele-1" />
3944         <severity value="error" />
3945         <human value="All FHIR elements must have a @value or children" />
3946         <expression value="hasValue() or (children().count() > id.count())" />
3947         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3948       </constraint>
3949       <mustSupport value="false" />
3950       <isModifier value="false" />
3951       <isSummary value="false" />
3952     </element>
3953     <element id="DeviceDefinition.hasPart">
3954       <path value="DeviceDefinition.hasPart" />
3955       <short value="A device, part of the current one" />
3956       <definition value="A device that is part (for example a component) of the present device." />
3957       <min value="0" />
3958       <max value="*" />
3959       <base>
3960         <path value="DeviceDefinition.hasPart" />
3961         <min value="0" />
3962         <max value="*" />
3963       </base>
3964       <type>
3965         <code value="BackboneElement" />
3966       </type>
3967       <constraint>
3968         <key value="ele-1" />
3969         <severity value="error" />
3970         <human value="All FHIR elements must have a @value or children" />
3971         <expression value="hasValue() or (children().count() > id.count())" />
3972         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
3973       </constraint>
3974       <mustSupport value="false" />
3975       <isModifier value="false" />
3976       <isSummary value="true" />
3977     </element>
3978     <element id="DeviceDefinition.hasPart.id">
3979       <path value="DeviceDefinition.hasPart.id" />
3980       <representation value="xmlAttr" />
3981       <short value="Unique id for inter-element referencing" />
3982       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
3983       <min value="0" />
3984       <max value="1" />
3985       <base>
3986         <path value="Element.id" />
3987         <min value="0" />
3988         <max value="1" />
3989       </base>
3990       <type>
3991         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
3992           <valueUrl value="string" />
3993         </extension>
3994         <code value="http://hl7.org/fhirpath/System.String" />
3995       </type>
3996       <condition value="ele-1" />
3997       <isModifier value="false" />
3998       <isSummary value="false" />
3999       <mapping>
4000         <identity value="rim" />
4001         <map value="n/a" />
4002       </mapping>
4003     </element>
4004     <element id="DeviceDefinition.hasPart.extension">
4005       <path value="DeviceDefinition.hasPart.extension" />
4006       <short value="Additional content defined by implementations" />
4007       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
4008       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
4009       <alias value="extensions" />
4010       <alias value="user content" />
4011       <min value="0" />
4012       <max value="*" />
4013       <base>
4014         <path value="Element.extension" />
4015         <min value="0" />
4016         <max value="*" />
4017       </base>
4018       <type>
4019         <code value="Extension" />
4020       </type>
4021       <constraint>
4022         <key value="ele-1" />
4023         <severity value="error" />
4024         <human value="All FHIR elements must have a @value or children" />
4025         <expression value="hasValue() or (children().count() > id.count())" />
4026         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4027       </constraint>
4028       <constraint>
4029         <key value="ext-1" />
4030         <severity value="error" />
4031         <human value="Must have either extensions or value[x], not both" />
4032         <expression value="extension.exists() != value.exists()" />
4033         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
4034       </constraint>
4035       <isModifier value="false" />
4036       <isSummary value="false" />
4037       <mapping>
4038         <identity value="rim" />
4039         <map value="n/a" />
4040       </mapping>
4041     </element>
4042     <element id="DeviceDefinition.hasPart.modifierExtension">
4043       <path value="DeviceDefinition.hasPart.modifierExtension" />
4044       <short value="Extensions that cannot be ignored even if unrecognized" />
4045       <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
4046       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
4047       <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)." />
4048       <alias value="extensions" />
4049       <alias value="user content" />
4050       <alias value="modifiers" />
4051       <min value="0" />
4052       <max value="*" />
4053       <base>
4054         <path value="BackboneElement.modifierExtension" />
4055         <min value="0" />
4056         <max value="*" />
4057       </base>
4058       <type>
4059         <code value="Extension" />
4060       </type>
4061       <constraint>
4062         <key value="ele-1" />
4063         <severity value="error" />
4064         <human value="All FHIR elements must have a @value or children" />
4065         <expression value="hasValue() or (children().count() > id.count())" />
4066         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4067       </constraint>
4068       <constraint>
4069         <key value="ext-1" />
4070         <severity value="error" />
4071         <human value="Must have either extensions or value[x], not both" />
4072         <expression value="extension.exists() != value.exists()" />
4073         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
4074       </constraint>
4075       <isModifier value="true" />
4076       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
4077       <isSummary value="true" />
4078       <mapping>
4079         <identity value="rim" />
4080         <map value="N/A" />
4081       </mapping>
4082     </element>
4083     <element id="DeviceDefinition.hasPart.reference">
4084       <path value="DeviceDefinition.hasPart.reference" />
4085       <short value="Reference to the part" />
4086       <definition value="Reference to the device that is part of the current device." />
4087       <min value="1" />
4088       <max value="1" />
4089       <base>
4090         <path value="DeviceDefinition.hasPart.reference" />
4091         <min value="1" />
4092         <max value="1" />
4093       </base>
4094       <type>
4095         <code value="Reference" />
4096         <targetProfile value="http://hl7.org/fhir/StructureDefinition/DeviceDefinition" />
4097       </type>
4098       <constraint>
4099         <key value="ele-1" />
4100         <severity value="error" />
4101         <human value="All FHIR elements must have a @value or children" />
4102         <expression value="hasValue() or (children().count() > id.count())" />
4103         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4104       </constraint>
4105       <mustSupport value="false" />
4106       <isModifier value="false" />
4107       <isSummary value="true" />
4108     </element>
4109     <element id="DeviceDefinition.hasPart.count">
4110       <path value="DeviceDefinition.hasPart.count" />
4111       <short value="Number of occurrences of the part" />
4112       <definition value="Number of instances of the component device in the current device." />
4113       <min value="0" />
4114       <max value="1" />
4115       <base>
4116         <path value="DeviceDefinition.hasPart.count" />
4117         <min value="0" />
4118         <max value="1" />
4119       </base>
4120       <type>
4121         <code value="integer" />
4122       </type>
4123       <constraint>
4124         <key value="ele-1" />
4125         <severity value="error" />
4126         <human value="All FHIR elements must have a @value or children" />
4127         <expression value="hasValue() or (children().count() > id.count())" />
4128         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4129       </constraint>
4130       <mustSupport value="true" />
4131       <isModifier value="false" />
4132       <isSummary value="false" />
4133     </element>
4134     <element id="DeviceDefinition.packaging">
4135       <path value="DeviceDefinition.packaging" />
4136       <short value="Information about the packaging of the device, i.e. how the device is packaged" />
4137       <definition value="Information about the packaging of the device, i.e. how the device is packaged." />
4138       <min value="0" />
4139       <max value="*" />
4140       <base>
4141         <path value="DeviceDefinition.packaging" />
4142         <min value="0" />
4143         <max value="*" />
4144       </base>
4145       <type>
4146         <code value="BackboneElement" />
4147       </type>
4148       <constraint>
4149         <key value="ele-1" />
4150         <severity value="error" />
4151         <human value="All FHIR elements must have a @value or children" />
4152         <expression value="hasValue() or (children().count() > id.count())" />
4153         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4154       </constraint>
4155       <mustSupport value="false" />
4156       <isModifier value="false" />
4157       <isSummary value="false" />
4158     </element>
4159     <element id="DeviceDefinition.packaging.id">
4160       <path value="DeviceDefinition.packaging.id" />
4161       <representation value="xmlAttr" />
4162       <short value="Unique id for inter-element referencing" />
4163       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
4164       <min value="0" />
4165       <max value="1" />
4166       <base>
4167         <path value="Element.id" />
4168         <min value="0" />
4169         <max value="1" />
4170       </base>
4171       <type>
4172         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
4173           <valueUrl value="string" />
4174         </extension>
4175         <code value="http://hl7.org/fhirpath/System.String" />
4176       </type>
4177       <condition value="ele-1" />
4178       <isModifier value="false" />
4179       <isSummary value="false" />
4180       <mapping>
4181         <identity value="rim" />
4182         <map value="n/a" />
4183       </mapping>
4184     </element>
4185     <element id="DeviceDefinition.packaging.extension">
4186       <path value="DeviceDefinition.packaging.extension" />
4187       <short value="Additional content defined by implementations" />
4188       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
4189       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
4190       <alias value="extensions" />
4191       <alias value="user content" />
4192       <min value="0" />
4193       <max value="*" />
4194       <base>
4195         <path value="Element.extension" />
4196         <min value="0" />
4197         <max value="*" />
4198       </base>
4199       <type>
4200         <code value="Extension" />
4201       </type>
4202       <constraint>
4203         <key value="ele-1" />
4204         <severity value="error" />
4205         <human value="All FHIR elements must have a @value or children" />
4206         <expression value="hasValue() or (children().count() > id.count())" />
4207         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4208       </constraint>
4209       <constraint>
4210         <key value="ext-1" />
4211         <severity value="error" />
4212         <human value="Must have either extensions or value[x], not both" />
4213         <expression value="extension.exists() != value.exists()" />
4214         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
4215       </constraint>
4216       <isModifier value="false" />
4217       <isSummary value="false" />
4218       <mapping>
4219         <identity value="rim" />
4220         <map value="n/a" />
4221       </mapping>
4222     </element>
4223     <element id="DeviceDefinition.packaging.modifierExtension">
4224       <path value="DeviceDefinition.packaging.modifierExtension" />
4225       <short value="Extensions that cannot be ignored even if unrecognized" />
4226       <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
4227       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
4228       <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)." />
4229       <alias value="extensions" />
4230       <alias value="user content" />
4231       <alias value="modifiers" />
4232       <min value="0" />
4233       <max value="*" />
4234       <base>
4235         <path value="BackboneElement.modifierExtension" />
4236         <min value="0" />
4237         <max value="*" />
4238       </base>
4239       <type>
4240         <code value="Extension" />
4241       </type>
4242       <constraint>
4243         <key value="ele-1" />
4244         <severity value="error" />
4245         <human value="All FHIR elements must have a @value or children" />
4246         <expression value="hasValue() or (children().count() > id.count())" />
4247         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4248       </constraint>
4249       <constraint>
4250         <key value="ext-1" />
4251         <severity value="error" />
4252         <human value="Must have either extensions or value[x], not both" />
4253         <expression value="extension.exists() != value.exists()" />
4254         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
4255       </constraint>
4256       <isModifier value="true" />
4257       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
4258       <isSummary value="true" />
4259       <mapping>
4260         <identity value="rim" />
4261         <map value="N/A" />
4262       </mapping>
4263     </element>
4264     <element id="DeviceDefinition.packaging.identifier">
4265       <path value="DeviceDefinition.packaging.identifier" />
4266       <short value="Business identifier of the packaged medication" />
4267       <definition value="The business identifier of the packaged medication." />
4268       <min value="0" />
4269       <max value="1" />
4270       <base>
4271         <path value="DeviceDefinition.packaging.identifier" />
4272         <min value="0" />
4273         <max value="1" />
4274       </base>
4275       <type>
4276         <code value="Identifier" />
4277       </type>
4278       <constraint>
4279         <key value="ele-1" />
4280         <severity value="error" />
4281         <human value="All FHIR elements must have a @value or children" />
4282         <expression value="hasValue() or (children().count() > id.count())" />
4283         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4284       </constraint>
4285       <mustSupport value="false" />
4286       <isModifier value="false" />
4287       <isSummary value="false" />
4288     </element>
4289     <element id="DeviceDefinition.packaging.type">
4290       <path value="DeviceDefinition.packaging.type" />
4291       <short value="A code that defines the specific type of packaging" />
4292       <definition value="A code that defines the specific type of packaging." />
4293       <min value="0" />
4294       <max value="1" />
4295       <base>
4296         <path value="DeviceDefinition.packaging.type" />
4297         <min value="0" />
4298         <max value="1" />
4299       </base>
4300       <type>
4301         <code value="CodeableConcept" />
4302       </type>
4303       <constraint>
4304         <key value="ele-1" />
4305         <severity value="error" />
4306         <human value="All FHIR elements must have a @value or children" />
4307         <expression value="hasValue() or (children().count() > id.count())" />
4308         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4309       </constraint>
4310       <mustSupport value="false" />
4311       <isModifier value="false" />
4312       <isSummary value="false" />
4313       <mapping>
4314         <identity value="devicedefinition-to-gudid" />
4315         <map value="Package Type" />
4316       </mapping>
4317     </element>
4318     <element id="DeviceDefinition.packaging.count">
4319       <path value="DeviceDefinition.packaging.count" />
4320       <short value="The number of items contained in the package (devices or sub-packages)" />
4321       <definition value="The number of items contained in the package (devices or sub-packages)." />
4322       <min value="0" />
4323       <max value="1" />
4324       <base>
4325         <path value="DeviceDefinition.packaging.count" />
4326         <min value="0" />
4327         <max value="1" />
4328       </base>
4329       <type>
4330         <code value="integer" />
4331       </type>
4332       <constraint>
4333         <key value="ele-1" />
4334         <severity value="error" />
4335         <human value="All FHIR elements must have a @value or children" />
4336         <expression value="hasValue() or (children().count() > id.count())" />
4337         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4338       </constraint>
4339       <mustSupport value="true" />
4340       <isModifier value="false" />
4341       <isSummary value="false" />
4342       <mapping>
4343         <identity value="devicedefinition-to-eudamed" />
4344         <map value="FLD-UDID-121|Quantity of item(s)" />
4345       </mapping>
4346       <mapping>
4347         <identity value="devicedefinition-to-gudid" />
4348         <map value="Quantity per Package" />
4349       </mapping>
4350     </element>
4351     <element id="DeviceDefinition.packaging.distributor">
4352       <path value="DeviceDefinition.packaging.distributor" />
4353       <short value="An organization that distributes the packaged device" />
4354       <definition value="An organization that distributes the packaged device." />
4355       <min value="0" />
4356       <max value="*" />
4357       <base>
4358         <path value="DeviceDefinition.packaging.distributor" />
4359         <min value="0" />
4360         <max value="*" />
4361       </base>
4362       <type>
4363         <code value="BackboneElement" />
4364       </type>
4365       <constraint>
4366         <key value="ele-1" />
4367         <severity value="error" />
4368         <human value="All FHIR elements must have a @value or children" />
4369         <expression value="hasValue() or (children().count() > id.count())" />
4370         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4371       </constraint>
4372       <mustSupport value="false" />
4373       <isModifier value="false" />
4374       <isSummary value="false" />
4375     </element>
4376     <element id="DeviceDefinition.packaging.distributor.id">
4377       <path value="DeviceDefinition.packaging.distributor.id" />
4378       <representation value="xmlAttr" />
4379       <short value="Unique id for inter-element referencing" />
4380       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
4381       <min value="0" />
4382       <max value="1" />
4383       <base>
4384         <path value="Element.id" />
4385         <min value="0" />
4386         <max value="1" />
4387       </base>
4388       <type>
4389         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
4390           <valueUrl value="string" />
4391         </extension>
4392         <code value="http://hl7.org/fhirpath/System.String" />
4393       </type>
4394       <condition value="ele-1" />
4395       <isModifier value="false" />
4396       <isSummary value="false" />
4397       <mapping>
4398         <identity value="rim" />
4399         <map value="n/a" />
4400       </mapping>
4401     </element>
4402     <element id="DeviceDefinition.packaging.distributor.extension">
4403       <path value="DeviceDefinition.packaging.distributor.extension" />
4404       <short value="Additional content defined by implementations" />
4405       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
4406       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
4407       <alias value="extensions" />
4408       <alias value="user content" />
4409       <min value="0" />
4410       <max value="*" />
4411       <base>
4412         <path value="Element.extension" />
4413         <min value="0" />
4414         <max value="*" />
4415       </base>
4416       <type>
4417         <code value="Extension" />
4418       </type>
4419       <constraint>
4420         <key value="ele-1" />
4421         <severity value="error" />
4422         <human value="All FHIR elements must have a @value or children" />
4423         <expression value="hasValue() or (children().count() > id.count())" />
4424         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4425       </constraint>
4426       <constraint>
4427         <key value="ext-1" />
4428         <severity value="error" />
4429         <human value="Must have either extensions or value[x], not both" />
4430         <expression value="extension.exists() != value.exists()" />
4431         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
4432       </constraint>
4433       <isModifier value="false" />
4434       <isSummary value="false" />
4435       <mapping>
4436         <identity value="rim" />
4437         <map value="n/a" />
4438       </mapping>
4439     </element>
4440     <element id="DeviceDefinition.packaging.distributor.modifierExtension">
4441       <path value="DeviceDefinition.packaging.distributor.modifierExtension" />
4442       <short value="Extensions that cannot be ignored even if unrecognized" />
4443       <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
4444       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
4445       <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)." />
4446       <alias value="extensions" />
4447       <alias value="user content" />
4448       <alias value="modifiers" />
4449       <min value="0" />
4450       <max value="*" />
4451       <base>
4452         <path value="BackboneElement.modifierExtension" />
4453         <min value="0" />
4454         <max value="*" />
4455       </base>
4456       <type>
4457         <code value="Extension" />
4458       </type>
4459       <constraint>
4460         <key value="ele-1" />
4461         <severity value="error" />
4462         <human value="All FHIR elements must have a @value or children" />
4463         <expression value="hasValue() or (children().count() > id.count())" />
4464         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4465       </constraint>
4466       <constraint>
4467         <key value="ext-1" />
4468         <severity value="error" />
4469         <human value="Must have either extensions or value[x], not both" />
4470         <expression value="extension.exists() != value.exists()" />
4471         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
4472       </constraint>
4473       <isModifier value="true" />
4474       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
4475       <isSummary value="true" />
4476       <mapping>
4477         <identity value="rim" />
4478         <map value="N/A" />
4479       </mapping>
4480     </element>
4481     <element id="DeviceDefinition.packaging.distributor.name">
4482       <path value="DeviceDefinition.packaging.distributor.name" />
4483       <short value="Distributor's human-readable name" />
4484       <definition value="Distributor's human-readable name." />
4485       <min value="0" />
4486       <max value="1" />
4487       <base>
4488         <path value="DeviceDefinition.packaging.distributor.name" />
4489         <min value="0" />
4490         <max value="1" />
4491       </base>
4492       <type>
4493         <code value="string" />
4494       </type>
4495       <constraint>
4496         <key value="ele-1" />
4497         <severity value="error" />
4498         <human value="All FHIR elements must have a @value or children" />
4499         <expression value="hasValue() or (children().count() > id.count())" />
4500         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4501       </constraint>
4502       <mustSupport value="false" />
4503       <isModifier value="false" />
4504       <isSummary value="false" />
4505     </element>
4506     <element id="DeviceDefinition.packaging.distributor.organizationReference">
4507       <path value="DeviceDefinition.packaging.distributor.organizationReference" />
4508       <short value="Distributor as an Organization resource" />
4509       <definition value="Distributor as an Organization resource." />
4510       <min value="0" />
4511       <max value="*" />
4512       <base>
4513         <path value="DeviceDefinition.packaging.distributor.organizationReference" />
4514         <min value="0" />
4515         <max value="*" />
4516       </base>
4517       <type>
4518         <code value="Reference" />
4519         <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization" />
4520       </type>
4521       <constraint>
4522         <key value="ele-1" />
4523         <severity value="error" />
4524         <human value="All FHIR elements must have a @value or children" />
4525         <expression value="hasValue() or (children().count() > id.count())" />
4526         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4527       </constraint>
4528       <mustSupport value="false" />
4529       <isModifier value="false" />
4530       <isSummary value="false" />
4531     </element>
4532     <element id="DeviceDefinition.packaging.udiDeviceIdentifier">
4533       <path value="DeviceDefinition.packaging.udiDeviceIdentifier" />
4534       <short value="Unique Device Identifier (UDI) Barcode string on the packaging" />
4535       <definition value="Unique Device Identifier (UDI) Barcode string on the packaging." />
4536       <min value="0" />
4537       <max value="*" />
4538       <base>
4539         <path value="DeviceDefinition.packaging.udiDeviceIdentifier" />
4540         <min value="0" />
4541         <max value="*" />
4542       </base>
4543       <type>
4544         <code value="BackboneElement" />
4545       </type>
4546       <constraint>
4547         <key value="ele-1" />
4548         <severity value="error" />
4549         <human value="All FHIR elements must have a @value or children" />
4550         <expression value="hasValue() or (children().count() > id.count())" />
4551         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4552       </constraint>
4553       <mustSupport value="true" />
4554       <isModifier value="false" />
4555       <isSummary value="false" />
4556     </element>
4557     <element id="DeviceDefinition.packaging.udiDeviceIdentifier.id">
4558       <path value="DeviceDefinition.packaging.udiDeviceIdentifier.id" />
4559       <representation value="xmlAttr" />
4560       <short value="Unique id for inter-element referencing" />
4561       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
4562       <min value="0" />
4563       <max value="1" />
4564       <base>
4565         <path value="Element.id" />
4566         <min value="0" />
4567         <max value="1" />
4568       </base>
4569       <type>
4570         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
4571           <valueUrl value="string" />
4572         </extension>
4573         <code value="http://hl7.org/fhirpath/System.String" />
4574       </type>
4575       <condition value="ele-1" />
4576       <isModifier value="false" />
4577       <isSummary value="false" />
4578       <mapping>
4579         <identity value="rim" />
4580         <map value="n/a" />
4581       </mapping>
4582     </element>
4583     <element id="DeviceDefinition.packaging.udiDeviceIdentifier.extension">
4584       <path value="DeviceDefinition.packaging.udiDeviceIdentifier.extension" />
4585       <short value="Additional content defined by implementations" />
4586       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
4587       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
4588       <alias value="extensions" />
4589       <alias value="user content" />
4590       <min value="0" />
4591       <max value="*" />
4592       <base>
4593         <path value="Element.extension" />
4594         <min value="0" />
4595         <max value="*" />
4596       </base>
4597       <type>
4598         <code value="Extension" />
4599       </type>
4600       <constraint>
4601         <key value="ele-1" />
4602         <severity value="error" />
4603         <human value="All FHIR elements must have a @value or children" />
4604         <expression value="hasValue() or (children().count() > id.count())" />
4605         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4606       </constraint>
4607       <constraint>
4608         <key value="ext-1" />
4609         <severity value="error" />
4610         <human value="Must have either extensions or value[x], not both" />
4611         <expression value="extension.exists() != value.exists()" />
4612         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
4613       </constraint>
4614       <isModifier value="false" />
4615       <isSummary value="false" />
4616       <mapping>
4617         <identity value="rim" />
4618         <map value="n/a" />
4619       </mapping>
4620     </element>
4621     <element id="DeviceDefinition.packaging.udiDeviceIdentifier.modifierExtension">
4622       <path value="DeviceDefinition.packaging.udiDeviceIdentifier.modifierExtension" />
4623       <short value="Extensions that cannot be ignored even if unrecognized" />
4624       <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
4625       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
4626       <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)." />
4627       <alias value="extensions" />
4628       <alias value="user content" />
4629       <alias value="modifiers" />
4630       <min value="0" />
4631       <max value="*" />
4632       <base>
4633         <path value="BackboneElement.modifierExtension" />
4634         <min value="0" />
4635         <max value="*" />
4636       </base>
4637       <type>
4638         <code value="Extension" />
4639       </type>
4640       <constraint>
4641         <key value="ele-1" />
4642         <severity value="error" />
4643         <human value="All FHIR elements must have a @value or children" />
4644         <expression value="hasValue() or (children().count() > id.count())" />
4645         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4646       </constraint>
4647       <constraint>
4648         <key value="ext-1" />
4649         <severity value="error" />
4650         <human value="Must have either extensions or value[x], not both" />
4651         <expression value="extension.exists() != value.exists()" />
4652         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
4653       </constraint>
4654       <isModifier value="true" />
4655       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
4656       <isSummary value="true" />
4657       <mapping>
4658         <identity value="rim" />
4659         <map value="N/A" />
4660       </mapping>
4661     </element>
4662     <element id="DeviceDefinition.packaging.udiDeviceIdentifier.deviceIdentifier">
4663       <path value="DeviceDefinition.packaging.udiDeviceIdentifier.deviceIdentifier" />
4664       <short value="The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier" />
4665       <definition value="The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier." />
4666       <min value="1" />
4667       <max value="1" />
4668       <base>
4669         <path value="DeviceDefinition.udiDeviceIdentifier.deviceIdentifier" />
4670         <min value="1" />
4671         <max value="1" />
4672       </base>
4673       <type>
4674         <code value="string" />
4675       </type>
4676       <constraint>
4677         <key value="ele-1" />
4678         <severity value="error" />
4679         <human value="All FHIR elements must have a @value or children" />
4680         <expression value="hasValue() or (children().count() > id.count())" />
4681         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4682       </constraint>
4683       <mustSupport value="false" />
4684       <isModifier value="false" />
4685       <isSummary value="false" />
4686       <mapping>
4687         <identity value="devicedefinition-to-eudamed" />
4688         <map value="FLD-UDID-120|Package UDI-DI" />
4689       </mapping>
4690       <mapping>
4691         <identity value="devicedefinition-to-gudid" />
4692         <map value="Package DI Number" />
4693       </mapping>
4694     </element>
4695     <element id="DeviceDefinition.packaging.udiDeviceIdentifier.issuer">
4696       <path value="DeviceDefinition.packaging.udiDeviceIdentifier.issuer" />
4697       <short value="The organization that assigns the identifier algorithm" />
4698       <definition value="Organization accredited by the jurisdictional authority to operate a system for the issuance of UDIs. Main issuers referenced in the US and/or in EU include:
1. GS1 GTIN: urn:oid:1.3.160,
2. HIBCC: urn:oid:2.16.840.1.113883.6.40,
3. ICCBBA Information Standard for Blood and Transplant (ISBT) 128: urn:oid:2.16.840.1.113883.6.18,
4. ICCBBA for other devices: to be found,
5. IFA (Europe Union only): to be found" />
4699       <min value="1" />
4700       <max value="1" />
4701       <base>
4702         <path value="DeviceDefinition.udiDeviceIdentifier.issuer" />
4703         <min value="1" />
4704         <max value="1" />
4705       </base>
4706       <type>
4707         <code value="uri" />
4708       </type>
4709       <constraint>
4710         <key value="ele-1" />
4711         <severity value="error" />
4712         <human value="All FHIR elements must have a @value or children" />
4713         <expression value="hasValue() or (children().count() > id.count())" />
4714         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4715       </constraint>
4716       <mustSupport value="false" />
4717       <isModifier value="false" />
4718       <isSummary value="false" />
4719     </element>
4720     <element id="DeviceDefinition.packaging.udiDeviceIdentifier.jurisdiction">
4721       <path value="DeviceDefinition.packaging.udiDeviceIdentifier.jurisdiction" />
4722       <short value="The jurisdiction to which the deviceIdentifier applies" />
4723       <definition value="The jurisdiction to which the deviceIdentifier applies." />
4724       <min value="1" />
4725       <max value="1" />
4726       <base>
4727         <path value="DeviceDefinition.udiDeviceIdentifier.jurisdiction" />
4728         <min value="1" />
4729         <max value="1" />
4730       </base>
4731       <type>
4732         <code value="uri" />
4733       </type>
4734       <constraint>
4735         <key value="ele-1" />
4736         <severity value="error" />
4737         <human value="All FHIR elements must have a @value or children" />
4738         <expression value="hasValue() or (children().count() > id.count())" />
4739         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4740       </constraint>
4741       <mustSupport value="false" />
4742       <isModifier value="false" />
4743       <isSummary value="false" />
4744       <mapping>
4745         <identity value="devicedefinition-to-gudid" />
4746         <map value="urn:oid:2.16.840.1.113883.3.150" />
4747       </mapping>
4748     </element>
4749     <element id="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution">
4750       <path value="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution" />
4751       <short value="Indicates whether and when the device is available on the market" />
4752       <definition value="Indicates where and when the device is available on the market." />
4753       <min value="0" />
4754       <max value="*" />
4755       <base>
4756         <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution" />
4757         <min value="0" />
4758         <max value="*" />
4759       </base>
4760       <type>
4761         <code value="BackboneElement" />
4762       </type>
4763       <constraint>
4764         <key value="ele-1" />
4765         <severity value="error" />
4766         <human value="All FHIR elements must have a @value or children" />
4767         <expression value="hasValue() or (children().count() > id.count())" />
4768         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4769       </constraint>
4770       <mustSupport value="false" />
4771       <isModifier value="false" />
4772       <isSummary value="false" />
4773     </element>
4774     <element id="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.id">
4775       <path value="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.id" />
4776       <representation value="xmlAttr" />
4777       <short value="Unique id for inter-element referencing" />
4778       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
4779       <min value="0" />
4780       <max value="1" />
4781       <base>
4782         <path value="Element.id" />
4783         <min value="0" />
4784         <max value="1" />
4785       </base>
4786       <type>
4787         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
4788           <valueUrl value="string" />
4789         </extension>
4790         <code value="http://hl7.org/fhirpath/System.String" />
4791       </type>
4792       <condition value="ele-1" />
4793       <isModifier value="false" />
4794       <isSummary value="false" />
4795       <mapping>
4796         <identity value="rim" />
4797         <map value="n/a" />
4798       </mapping>
4799     </element>
4800     <element id="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.extension">
4801       <path value="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.extension" />
4802       <short value="Additional content defined by implementations" />
4803       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
4804       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
4805       <alias value="extensions" />
4806       <alias value="user content" />
4807       <min value="0" />
4808       <max value="*" />
4809       <base>
4810         <path value="Element.extension" />
4811         <min value="0" />
4812         <max value="*" />
4813       </base>
4814       <type>
4815         <code value="Extension" />
4816       </type>
4817       <constraint>
4818         <key value="ele-1" />
4819         <severity value="error" />
4820         <human value="All FHIR elements must have a @value or children" />
4821         <expression value="hasValue() or (children().count() > id.count())" />
4822         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4823       </constraint>
4824       <constraint>
4825         <key value="ext-1" />
4826         <severity value="error" />
4827         <human value="Must have either extensions or value[x], not both" />
4828         <expression value="extension.exists() != value.exists()" />
4829         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
4830       </constraint>
4831       <isModifier value="false" />
4832       <isSummary value="false" />
4833       <mapping>
4834         <identity value="rim" />
4835         <map value="n/a" />
4836       </mapping>
4837     </element>
4838     <element id="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.modifierExtension">
4839       <path value="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.modifierExtension" />
4840       <short value="Extensions that cannot be ignored even if unrecognized" />
4841       <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
4842       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
4843       <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)." />
4844       <alias value="extensions" />
4845       <alias value="user content" />
4846       <alias value="modifiers" />
4847       <min value="0" />
4848       <max value="*" />
4849       <base>
4850         <path value="BackboneElement.modifierExtension" />
4851         <min value="0" />
4852         <max value="*" />
4853       </base>
4854       <type>
4855         <code value="Extension" />
4856       </type>
4857       <constraint>
4858         <key value="ele-1" />
4859         <severity value="error" />
4860         <human value="All FHIR elements must have a @value or children" />
4861         <expression value="hasValue() or (children().count() > id.count())" />
4862         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4863       </constraint>
4864       <constraint>
4865         <key value="ext-1" />
4866         <severity value="error" />
4867         <human value="Must have either extensions or value[x], not both" />
4868         <expression value="extension.exists() != value.exists()" />
4869         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
4870       </constraint>
4871       <isModifier value="true" />
4872       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
4873       <isSummary value="true" />
4874       <mapping>
4875         <identity value="rim" />
4876         <map value="N/A" />
4877       </mapping>
4878     </element>
4879     <element id="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod">
4880       <path value="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod" />
4881       <short value="Begin and end dates for the commercial distribution of the device" />
4882       <definition value="Begin and end dates for the commercial distribution of the device." />
4883       <min value="1" />
4884       <max value="1" />
4885       <base>
4886         <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod" />
4887         <min value="1" />
4888         <max value="1" />
4889       </base>
4890       <type>
4891         <code value="Period" />
4892       </type>
4893       <constraint>
4894         <key value="ele-1" />
4895         <severity value="error" />
4896         <human value="All FHIR elements must have a @value or children" />
4897         <expression value="hasValue() or (children().count() > id.count())" />
4898         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4899       </constraint>
4900       <mustSupport value="false" />
4901       <isModifier value="false" />
4902       <isSummary value="false" />
4903     </element>
4904     <element id="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.id">
4905       <path value="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.id" />
4906       <representation value="xmlAttr" />
4907       <short value="Unique id for inter-element referencing" />
4908       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
4909       <min value="0" />
4910       <max value="1" />
4911       <base>
4912         <path value="Element.id" />
4913         <min value="0" />
4914         <max value="1" />
4915       </base>
4916       <type>
4917         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
4918           <valueUrl value="id" />
4919         </extension>
4920         <code value="http://hl7.org/fhirpath/System.String" />
4921       </type>
4922       <condition value="ele-1" />
4923       <isModifier value="false" />
4924       <isSummary value="false" />
4925       <mapping>
4926         <identity value="rim" />
4927         <map value="n/a" />
4928       </mapping>
4929     </element>
4930     <element id="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.extension">
4931       <path value="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.extension" />
4932       <slicing>
4933         <discriminator>
4934           <type value="value" />
4935           <path value="url" />
4936         </discriminator>
4937         <description value="Extensions are always sliced by (at least) url" />
4938         <rules value="open" />
4939       </slicing>
4940       <short value="Additional content defined by implementations" />
4941       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
4942       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
4943       <alias value="extensions" />
4944       <alias value="user content" />
4945       <min value="0" />
4946       <max value="*" />
4947       <base>
4948         <path value="Element.extension" />
4949         <min value="0" />
4950         <max value="*" />
4951       </base>
4952       <type>
4953         <code value="Extension" />
4954       </type>
4955       <constraint>
4956         <key value="ele-1" />
4957         <severity value="error" />
4958         <human value="All FHIR elements must have a @value or children" />
4959         <expression value="hasValue() or (children().count() > id.count())" />
4960         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4961       </constraint>
4962       <constraint>
4963         <key value="ext-1" />
4964         <severity value="error" />
4965         <human value="Must have either extensions or value[x], not both" />
4966         <expression value="extension.exists() != value.exists()" />
4967         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
4968       </constraint>
4969       <isModifier value="false" />
4970       <isSummary value="false" />
4971       <mapping>
4972         <identity value="rim" />
4973         <map value="n/a" />
4974       </mapping>
4975     </element>
4976     <element id="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.start">
4977       <path value="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.start" />
4978       <short value="Starting time with inclusive boundary" />
4979       <definition value="The start of the period. The boundary is inclusive." />
4980       <comment value="If the low element is missing, the meaning is that the low boundary is not known." />
4981       <min value="0" />
4982       <max value="1" />
4983       <base>
4984         <path value="Period.start" />
4985         <min value="0" />
4986         <max value="1" />
4987       </base>
4988       <type>
4989         <code value="dateTime" />
4990       </type>
4991       <condition value="per-1" />
4992       <constraint>
4993         <key value="ele-1" />
4994         <severity value="error" />
4995         <human value="All FHIR elements must have a @value or children" />
4996         <expression value="hasValue() or (children().count() > id.count())" />
4997         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
4998       </constraint>
4999       <isModifier value="false" />
5000       <isSummary value="true" />
5001       <mapping>
5002         <identity value="v2" />
5003         <map value="DR.1" />
5004       </mapping>
5005       <mapping>
5006         <identity value="rim" />
5007         <map value="./low" />
5008       </mapping>
5009     </element>
5010     <element id="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.end">
5011       <path value="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.end" />
5012       <short value="End time with inclusive boundary, if not ongoing" />
5013       <definition value="The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time." />
5014       <comment value="The end value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03." />
5015       <min value="0" />
5016       <max value="1" />
5017       <base>
5018         <path value="Period.end" />
5019         <min value="0" />
5020         <max value="1" />
5021       </base>
5022       <type>
5023         <code value="dateTime" />
5024       </type>
5025       <meaningWhenMissing value="If the end of the period is missing, it means that the period is ongoing" />
5026       <condition value="per-1" />
5027       <constraint>
5028         <key value="ele-1" />
5029         <severity value="error" />
5030         <human value="All FHIR elements must have a @value or children" />
5031         <expression value="hasValue() or (children().count() > id.count())" />
5032         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5033       </constraint>
5034       <isModifier value="false" />
5035       <isSummary value="true" />
5036       <mapping>
5037         <identity value="devicedefinition-to-gudid" />
5038         <map value="Package Discontinue Date" />
5039       </mapping>
5040       <mapping>
5041         <identity value="v2" />
5042         <map value="DR.2" />
5043       </mapping>
5044       <mapping>
5045         <identity value="rim" />
5046         <map value="./high" />
5047       </mapping>
5048     </element>
5049     <element id="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.subJurisdiction">
5050       <path value="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.subJurisdiction" />
5051       <short value="National state or territory where the device is commercialized" />
5052       <definition value="National state or territory to which the marketDistribution recers, typically where the device is commercialized." />
5053       <min value="1" />
5054       <max value="1" />
5055       <base>
5056         <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction" />
5057         <min value="1" />
5058         <max value="1" />
5059       </base>
5060       <type>
5061         <code value="uri" />
5062       </type>
5063       <constraint>
5064         <key value="ele-1" />
5065         <severity value="error" />
5066         <human value="All FHIR elements must have a @value or children" />
5067         <expression value="hasValue() or (children().count() > id.count())" />
5068         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5069       </constraint>
5070       <mustSupport value="false" />
5071       <isModifier value="false" />
5072       <isSummary value="false" />
5073       <mapping>
5074         <identity value="devicedefinition-to-gudid" />
5075         <map value="urn:oid:2.16.840.1.113883.3.150" />
5076       </mapping>
5077     </element>
5078     <element id="DeviceDefinition.packaging.packaging">
5079       <path value="DeviceDefinition.packaging.packaging" />
5080       <short value="Allows packages within packages" />
5081       <definition value="Allows packages within packages." />
5082       <min value="0" />
5083       <max value="*" />
5084       <base>
5085         <path value="DeviceDefinition.packaging.packaging" />
5086         <min value="0" />
5087         <max value="*" />
5088       </base>
5089       <contentReference value="http://hl7.org/fhir/StructureDefinition/DeviceDefinition#DeviceDefinition.packaging" />
5090       <constraint>
5091         <key value="ele-1" />
5092         <severity value="error" />
5093         <human value="All FHIR elements must have a @value or children" />
5094         <expression value="hasValue() or (children().count() > id.count())" />
5095         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5096       </constraint>
5097       <mustSupport value="false" />
5098       <isModifier value="false" />
5099       <isSummary value="false" />
5100     </element>
5101     <element id="DeviceDefinition.version">
5102       <path value="DeviceDefinition.version" />
5103       <short value="The version of the device or software" />
5104       <definition value="The version of the device or software." />
5105       <min value="0" />
5106       <max value="*" />
5107       <base>
5108         <path value="DeviceDefinition.version" />
5109         <min value="0" />
5110         <max value="*" />
5111       </base>
5112       <type>
5113         <code value="BackboneElement" />
5114       </type>
5115       <constraint>
5116         <key value="ele-1" />
5117         <severity value="error" />
5118         <human value="All FHIR elements must have a @value or children" />
5119         <expression value="hasValue() or (children().count() > id.count())" />
5120         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5121       </constraint>
5122       <mustSupport value="false" />
5123       <isModifier value="false" />
5124       <isSummary value="false" />
5125     </element>
5126     <element id="DeviceDefinition.version.id">
5127       <path value="DeviceDefinition.version.id" />
5128       <representation value="xmlAttr" />
5129       <short value="Unique id for inter-element referencing" />
5130       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
5131       <min value="0" />
5132       <max value="1" />
5133       <base>
5134         <path value="Element.id" />
5135         <min value="0" />
5136         <max value="1" />
5137       </base>
5138       <type>
5139         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
5140           <valueUrl value="string" />
5141         </extension>
5142         <code value="http://hl7.org/fhirpath/System.String" />
5143       </type>
5144       <condition value="ele-1" />
5145       <isModifier value="false" />
5146       <isSummary value="false" />
5147       <mapping>
5148         <identity value="rim" />
5149         <map value="n/a" />
5150       </mapping>
5151     </element>
5152     <element id="DeviceDefinition.version.extension">
5153       <path value="DeviceDefinition.version.extension" />
5154       <short value="Additional content defined by implementations" />
5155       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
5156       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
5157       <alias value="extensions" />
5158       <alias value="user content" />
5159       <min value="0" />
5160       <max value="*" />
5161       <base>
5162         <path value="Element.extension" />
5163         <min value="0" />
5164         <max value="*" />
5165       </base>
5166       <type>
5167         <code value="Extension" />
5168       </type>
5169       <constraint>
5170         <key value="ele-1" />
5171         <severity value="error" />
5172         <human value="All FHIR elements must have a @value or children" />
5173         <expression value="hasValue() or (children().count() > id.count())" />
5174         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5175       </constraint>
5176       <constraint>
5177         <key value="ext-1" />
5178         <severity value="error" />
5179         <human value="Must have either extensions or value[x], not both" />
5180         <expression value="extension.exists() != value.exists()" />
5181         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
5182       </constraint>
5183       <isModifier value="false" />
5184       <isSummary value="false" />
5185       <mapping>
5186         <identity value="rim" />
5187         <map value="n/a" />
5188       </mapping>
5189     </element>
5190     <element id="DeviceDefinition.version.modifierExtension">
5191       <path value="DeviceDefinition.version.modifierExtension" />
5192       <short value="Extensions that cannot be ignored even if unrecognized" />
5193       <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
5194       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
5195       <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)." />
5196       <alias value="extensions" />
5197       <alias value="user content" />
5198       <alias value="modifiers" />
5199       <min value="0" />
5200       <max value="*" />
5201       <base>
5202         <path value="BackboneElement.modifierExtension" />
5203         <min value="0" />
5204         <max value="*" />
5205       </base>
5206       <type>
5207         <code value="Extension" />
5208       </type>
5209       <constraint>
5210         <key value="ele-1" />
5211         <severity value="error" />
5212         <human value="All FHIR elements must have a @value or children" />
5213         <expression value="hasValue() or (children().count() > id.count())" />
5214         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5215       </constraint>
5216       <constraint>
5217         <key value="ext-1" />
5218         <severity value="error" />
5219         <human value="Must have either extensions or value[x], not both" />
5220         <expression value="extension.exists() != value.exists()" />
5221         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
5222       </constraint>
5223       <isModifier value="true" />
5224       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
5225       <isSummary value="true" />
5226       <mapping>
5227         <identity value="rim" />
5228         <map value="N/A" />
5229       </mapping>
5230     </element>
5231     <element id="DeviceDefinition.version.type">
5232       <path value="DeviceDefinition.version.type" />
5233       <short value="The type of the device version, e.g. manufacturer, approved, internal" />
5234       <definition value="The type of the device version, e.g. manufacturer, approved, internal." />
5235       <alias value="Σ" />
5236       <min value="0" />
5237       <max value="1" />
5238       <base>
5239         <path value="DeviceDefinition.version.type" />
5240         <min value="0" />
5241         <max value="1" />
5242       </base>
5243       <type>
5244         <code value="CodeableConcept" />
5245       </type>
5246       <constraint>
5247         <key value="ele-1" />
5248         <severity value="error" />
5249         <human value="All FHIR elements must have a @value or children" />
5250         <expression value="hasValue() or (children().count() > id.count())" />
5251         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5252       </constraint>
5253       <mustSupport value="false" />
5254       <isModifier value="false" />
5255       <isSummary value="false" />
5256     </element>
5257     <element id="DeviceDefinition.version.component">
5258       <path value="DeviceDefinition.version.component" />
5259       <short value="The hardware or software module of the device to which the version applies" />
5260       <definition value="The hardware or software module of the device to which the version applies." />
5261       <comment value="Note that the module of the device would not need to be tracked as a separate device, e.g., using different UDI, thus would typically involve one or more software modules. For example, a device may involve two software modules each on a different version." />
5262       <min value="0" />
5263       <max value="1" />
5264       <base>
5265         <path value="DeviceDefinition.version.component" />
5266         <min value="0" />
5267         <max value="1" />
5268       </base>
5269       <type>
5270         <code value="Identifier" />
5271       </type>
5272       <constraint>
5273         <key value="ele-1" />
5274         <severity value="error" />
5275         <human value="All FHIR elements must have a @value or children" />
5276         <expression value="hasValue() or (children().count() > id.count())" />
5277         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5278       </constraint>
5279       <mustSupport value="false" />
5280       <isModifier value="false" />
5281       <isSummary value="false" />
5282       <mapping>
5283         <identity value="w5" />
5284         <map value="FiveWs.what[x]" />
5285       </mapping>
5286     </element>
5287     <element id="DeviceDefinition.version.value">
5288       <path value="DeviceDefinition.version.value" />
5289       <short value="The version text" />
5290       <definition value="The version text." />
5291       <min value="1" />
5292       <max value="1" />
5293       <base>
5294         <path value="DeviceDefinition.version.value" />
5295         <min value="1" />
5296         <max value="1" />
5297       </base>
5298       <type>
5299         <code value="string" />
5300       </type>
5301       <constraint>
5302         <key value="ele-1" />
5303         <severity value="error" />
5304         <human value="All FHIR elements must have a @value or children" />
5305         <expression value="hasValue() or (children().count() > id.count())" />
5306         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5307       </constraint>
5308       <mustSupport value="false" />
5309       <isModifier value="false" />
5310       <isSummary value="false" />
5311     </element>
5312     <element id="DeviceDefinition.safety">
5313       <path value="DeviceDefinition.safety" />
5314       <short value="Safety characteristics of the device" />
5315       <definition value="Safety characteristics of the device." />
5316       <min value="0" />
5317       <max value="*" />
5318       <base>
5319         <path value="DeviceDefinition.safety" />
5320         <min value="0" />
5321         <max value="*" />
5322       </base>
5323       <type>
5324         <code value="CodeableConcept" />
5325       </type>
5326       <constraint>
5327         <key value="ele-1" />
5328         <severity value="error" />
5329         <human value="All FHIR elements must have a @value or children" />
5330         <expression value="hasValue() or (children().count() > id.count())" />
5331         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5332       </constraint>
5333       <mustSupport value="true" />
5334       <isModifier value="false" />
5335       <isSummary value="true" />
5336       <binding>
5337         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
5338           <valueString value="Safety" />
5339         </extension>
5340         <strength value="example" />
5341         <valueSet value="http://hl7.org/fhir/ValueSet/device-safety" />
5342       </binding>
5343       <mapping>
5344         <identity value="devicedefinition-to-eudamed" />
5345         <map value="FLD-UDID-212|Critical Warnings type: {CW025:MR SAFE, CW026:MR CONDITIONAL, CW027:MR UNSAFE, CW023:Consider hazards from magnetic fields, CW024:Do not store near magnets or magnetic devices},FLD-UDID-156|Containing latex (Boolean)" />
5346       </mapping>
5347       <mapping>
5348         <identity value="devicedefinition-to-gudid" />
5349         <map value="What MRI safety information does the labeling contain?,Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437),Device labeled as "Not made with natural rubber latex"" />
5350       </mapping>
5351     </element>
5352     <element id="DeviceDefinition.shelfLifeStorage">
5353       <path value="DeviceDefinition.shelfLifeStorage" />
5354       <short value="Shelf Life and storage information" />
5355       <definition value="Shelf Life and storage information." />
5356       <min value="0" />
5357       <max value="*" />
5358       <base>
5359         <path value="DeviceDefinition.shelfLifeStorage" />
5360         <min value="0" />
5361         <max value="*" />
5362       </base>
5363       <type>
5364         <code value="ProductShelfLife" />
5365       </type>
5366       <constraint>
5367         <key value="ele-1" />
5368         <severity value="error" />
5369         <human value="All FHIR elements must have a @value or children" />
5370         <expression value="hasValue() or (children().count() > id.count())" />
5371         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5372       </constraint>
5373       <mustSupport value="false" />
5374       <isModifier value="false" />
5375       <isSummary value="false" />
5376     </element>
5377     <element id="DeviceDefinition.languageCode">
5378       <path value="DeviceDefinition.languageCode" />
5379       <short value="Language code for the human-readable text strings produced by the device (all supported)" />
5380       <definition value="Language code for the human-readable text strings produced by the device (all supported)." />
5381       <min value="0" />
5382       <max value="*" />
5383       <base>
5384         <path value="DeviceDefinition.languageCode" />
5385         <min value="0" />
5386         <max value="*" />
5387       </base>
5388       <type>
5389         <code value="CodeableConcept" />
5390       </type>
5391       <constraint>
5392         <key value="ele-1" />
5393         <severity value="error" />
5394         <human value="All FHIR elements must have a @value or children" />
5395         <expression value="hasValue() or (children().count() > id.count())" />
5396         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5397       </constraint>
5398       <mustSupport value="false" />
5399       <isModifier value="false" />
5400       <isSummary value="false" />
5401     </element>
5402     <element id="DeviceDefinition.property">
5403       <path value="DeviceDefinition.property" />
5404       <short value="Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc" />
5405       <definition value="Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes." />
5406       <comment value="Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation.  Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition." />
5407       <min value="0" />
5408       <max value="*" />
5409       <base>
5410         <path value="DeviceDefinition.property" />
5411         <min value="0" />
5412         <max value="*" />
5413       </base>
5414       <type>
5415         <code value="BackboneElement" />
5416       </type>
5417       <constraint>
5418         <key value="ele-1" />
5419         <severity value="error" />
5420         <human value="All FHIR elements must have a @value or children" />
5421         <expression value="hasValue() or (children().count() > id.count())" />
5422         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5423       </constraint>
5424       <mustSupport value="true" />
5425       <isModifier value="false" />
5426       <isSummary value="false" />
5427       <mapping>
5428         <identity value="devicedefinition-to-eudamed" />
5429         <map value="FLD-UDID-16|Risk Class: {Medical Devices: CLASS_I, CLASS_IIa, CLASS_IIb, CLASS_III} {In Vitro Diagnostic Devices: CLASS_A, CLASS_B, CLASS_C, CLASS_D},FLD-UDID-18|Tissues and cells - Presence of animal tissues or Cells, or their derivates (Boolean),FLD-UDID-34|Tissues and cells - Presence of cells or substances of microbial origin (Boolean),FLD-UDID-23|Tissues and cells - presence of human tissues or cells, or their derivates (Boolean),FLD-UDID-28|Active Device (Boolean),FLD-UDID-29|Device Intended to administer and/or Remove medicinal product (Boolean),FLD-UDID-30|Implantable (Boolean),FLD-UDID-31|Measuring Function (Boolean),FLD-UDID-32|Reusable Surgical Instruments (Boolean),FLD-UDID-33|Companion Diagnostic (Boolean),FLD-UDID-35|Near Patient Testing (Boolean),FLD-UDID-36|Patient Self Testing (Boolean),FLD-UDID-155|Presence of a substance which, if used separately, may be considered to be a medicinal product derived from human blood or plasma (Boolean),FLD-UDID-158|Presence of substance which, if used separately, may be considered to be a medicinal product (Boolean),FLD-UDID-262|Reagent (Boolean),FLD-UDID-263|Professional Testing (Boolean),FLD-UDID-264|Instrument (Boolean),FLD-UDID-356|Kit (Boolean),FLD-UDID-12|Device, Procedure pack or System {SYSTEM, PROCEDURE_PACK, DEVICE},FLD-UDID-167|Labelled as single use (Boolean),FLD-UDID-169|Device labelled Sterile,FLD-UDID-170|Need for sterilisation before use,FLD-UDID-146|Clinical Sizes {Angle, Diameter, Gauge, Inflation volume, Length, Pressure, Size, Volume, Width, Weight, Heigth, Wavelength, Frequency,...},Handling Environment Temperature" />
5430       </mapping>
5431       <mapping>
5432         <identity value="devicedefinition-to-gudid" />
5433         <map value="For Single-Use,Prescription Use (Rx),Over the Counter (OTC),Kit,Combination Product,Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P),Device Packaged as Sterile,Requires Sterilization Prior to Use,Storage Environment Temperature,Handling Environment Temperature,Size - Length,Size - Width,Size - Heigth,Size - Angle" />
5434       </mapping>
5435     </element>
5436     <element id="DeviceDefinition.property.id">
5437       <path value="DeviceDefinition.property.id" />
5438       <representation value="xmlAttr" />
5439       <short value="Unique id for inter-element referencing" />
5440       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
5441       <min value="0" />
5442       <max value="1" />
5443       <base>
5444         <path value="Element.id" />
5445         <min value="0" />
5446         <max value="1" />
5447       </base>
5448       <type>
5449         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
5450           <valueUrl value="string" />
5451         </extension>
5452         <code value="http://hl7.org/fhirpath/System.String" />
5453       </type>
5454       <condition value="ele-1" />
5455       <isModifier value="false" />
5456       <isSummary value="false" />
5457       <mapping>
5458         <identity value="rim" />
5459         <map value="n/a" />
5460       </mapping>
5461     </element>
5462     <element id="DeviceDefinition.property.extension">
5463       <path value="DeviceDefinition.property.extension" />
5464       <short value="Additional content defined by implementations" />
5465       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
5466       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
5467       <alias value="extensions" />
5468       <alias value="user content" />
5469       <min value="0" />
5470       <max value="*" />
5471       <base>
5472         <path value="Element.extension" />
5473         <min value="0" />
5474         <max value="*" />
5475       </base>
5476       <type>
5477         <code value="Extension" />
5478       </type>
5479       <constraint>
5480         <key value="ele-1" />
5481         <severity value="error" />
5482         <human value="All FHIR elements must have a @value or children" />
5483         <expression value="hasValue() or (children().count() > id.count())" />
5484         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5485       </constraint>
5486       <constraint>
5487         <key value="ext-1" />
5488         <severity value="error" />
5489         <human value="Must have either extensions or value[x], not both" />
5490         <expression value="extension.exists() != value.exists()" />
5491         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
5492       </constraint>
5493       <isModifier value="false" />
5494       <isSummary value="false" />
5495       <mapping>
5496         <identity value="rim" />
5497         <map value="n/a" />
5498       </mapping>
5499     </element>
5500     <element id="DeviceDefinition.property.modifierExtension">
5501       <path value="DeviceDefinition.property.modifierExtension" />
5502       <short value="Extensions that cannot be ignored even if unrecognized" />
5503       <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
5504       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
5505       <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)." />
5506       <alias value="extensions" />
5507       <alias value="user content" />
5508       <alias value="modifiers" />
5509       <min value="0" />
5510       <max value="*" />
5511       <base>
5512         <path value="BackboneElement.modifierExtension" />
5513         <min value="0" />
5514         <max value="*" />
5515       </base>
5516       <type>
5517         <code value="Extension" />
5518       </type>
5519       <constraint>
5520         <key value="ele-1" />
5521         <severity value="error" />
5522         <human value="All FHIR elements must have a @value or children" />
5523         <expression value="hasValue() or (children().count() > id.count())" />
5524         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5525       </constraint>
5526       <constraint>
5527         <key value="ext-1" />
5528         <severity value="error" />
5529         <human value="Must have either extensions or value[x], not both" />
5530         <expression value="extension.exists() != value.exists()" />
5531         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
5532       </constraint>
5533       <isModifier value="true" />
5534       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
5535       <isSummary value="true" />
5536       <mapping>
5537         <identity value="rim" />
5538         <map value="N/A" />
5539       </mapping>
5540     </element>
5541     <element id="DeviceDefinition.property.type">
5542       <path value="DeviceDefinition.property.type" />
5543       <short value="Code that specifies the property being represented" />
5544       <definition value="Code that specifies the property such as a resolution or color being represented." />
5545       <min value="1" />
5546       <max value="1" />
5547       <base>
5548         <path value="DeviceDefinition.property.type" />
5549         <min value="1" />
5550         <max value="1" />
5551       </base>
5552       <type>
5553         <code value="CodeableConcept" />
5554       </type>
5555       <constraint>
5556         <key value="ele-1" />
5557         <severity value="error" />
5558         <human value="All FHIR elements must have a @value or children" />
5559         <expression value="hasValue() or (children().count() > id.count())" />
5560         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5561       </constraint>
5562       <mustSupport value="false" />
5563       <isModifier value="false" />
5564       <isSummary value="false" />
5565       <binding>
5566         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
5567           <valueString value="DevicePropertyType" />
5568         </extension>
5569         <strength value="example" />
5570         <description value="Device property type." />
5571         <valueSet value="http://hl7.org/fhir/ValueSet/device-property-type" />
5572       </binding>
5573     </element>
5574     <element id="DeviceDefinition.property.value[x]">
5575       <path value="DeviceDefinition.property.value[x]" />
5576       <short value="Value of the property" />
5577       <definition value="The value of the property specified by the associated property.type code." />
5578       <comment value="This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements." />
5579       <min value="1" />
5580       <max value="1" />
5581       <base>
5582         <path value="DeviceDefinition.property.value[x]" />
5583         <min value="1" />
5584         <max value="1" />
5585       </base>
5586       <type>
5587         <code value="Quantity" />
5588       </type>
5589       <type>
5590         <code value="CodeableConcept" />
5591       </type>
5592       <type>
5593         <code value="string" />
5594       </type>
5595       <type>
5596         <code value="boolean" />
5597       </type>
5598       <type>
5599         <code value="integer" />
5600       </type>
5601       <type>
5602         <code value="Range" />
5603       </type>
5604       <type>
5605         <code value="Attachment" />
5606       </type>
5607       <constraint>
5608         <key value="ele-1" />
5609         <severity value="error" />
5610         <human value="All FHIR elements must have a @value or children" />
5611         <expression value="hasValue() or (children().count() > id.count())" />
5612         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5613       </constraint>
5614       <mustSupport value="false" />
5615       <isModifier value="false" />
5616       <isSummary value="false" />
5617     </element>
5618     <element id="DeviceDefinition.owner">
5619       <path value="DeviceDefinition.owner" />
5620       <short value="Organization responsible for device" />
5621       <definition value="An organization that is responsible for the provision and ongoing maintenance of the device." />
5622       <min value="0" />
5623       <max value="1" />
5624       <base>
5625         <path value="DeviceDefinition.owner" />
5626         <min value="0" />
5627         <max value="1" />
5628       </base>
5629       <type>
5630         <code value="Reference" />
5631         <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization" />
5632       </type>
5633       <constraint>
5634         <key value="ele-1" />
5635         <severity value="error" />
5636         <human value="All FHIR elements must have a @value or children" />
5637         <expression value="hasValue() or (children().count() > id.count())" />
5638         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5639       </constraint>
5640       <mustSupport value="false" />
5641       <isModifier value="false" />
5642       <isSummary value="false" />
5643       <mapping>
5644         <identity value="w5" />
5645         <map value="FiveWs.source" />
5646       </mapping>
5647       <mapping>
5648         <identity value="rim" />
5649         <map value=".playedRole[typeCode=OWN].scoper" />
5650       </mapping>
5651     </element>
5652     <element id="DeviceDefinition.contact">
5653       <path value="DeviceDefinition.contact" />
5654       <short value="Details for human/organization for support" />
5655       <definition value="Contact details for an organization or a particular human that is responsible for the device." />
5656       <comment value="used for troubleshooting etc." />
5657       <min value="0" />
5658       <max value="*" />
5659       <base>
5660         <path value="DeviceDefinition.contact" />
5661         <min value="0" />
5662         <max value="*" />
5663       </base>
5664       <type>
5665         <code value="ContactPoint" />
5666       </type>
5667       <constraint>
5668         <key value="ele-1" />
5669         <severity value="error" />
5670         <human value="All FHIR elements must have a @value or children" />
5671         <expression value="hasValue() or (children().count() > id.count())" />
5672         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5673       </constraint>
5674       <mustSupport value="false" />
5675       <isModifier value="false" />
5676       <isSummary value="false" />
5677       <mapping>
5678         <identity value="devicedefinition-to-eudamed" />
5679         <map value="FLD-UDID-354|Contact Details" />
5680       </mapping>
5681       <mapping>
5682         <identity value="devicedefinition-to-gudid" />
5683         <map value="CUSTOMER CONTACT" />
5684       </mapping>
5685       <mapping>
5686         <identity value="w5" />
5687         <map value="FiveWs.source" />
5688       </mapping>
5689       <mapping>
5690         <identity value="rim" />
5691         <map value=".scopedRole[typeCode=CON].player" />
5692       </mapping>
5693     </element>
5694     <element id="DeviceDefinition.link">
5695       <path value="DeviceDefinition.link" />
5696       <short value="An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device" />
5697       <definition value="An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device." />
5698       <min value="0" />
5699       <max value="*" />
5700       <base>
5701         <path value="DeviceDefinition.link" />
5702         <min value="0" />
5703         <max value="*" />
5704       </base>
5705       <type>
5706         <code value="BackboneElement" />
5707       </type>
5708       <constraint>
5709         <key value="ele-1" />
5710         <severity value="error" />
5711         <human value="All FHIR elements must have a @value or children" />
5712         <expression value="hasValue() or (children().count() > id.count())" />
5713         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5714       </constraint>
5715       <mustSupport value="false" />
5716       <isModifier value="false" />
5717       <isSummary value="false" />
5718     </element>
5719     <element id="DeviceDefinition.link.id">
5720       <path value="DeviceDefinition.link.id" />
5721       <representation value="xmlAttr" />
5722       <short value="Unique id for inter-element referencing" />
5723       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
5724       <min value="0" />
5725       <max value="1" />
5726       <base>
5727         <path value="Element.id" />
5728         <min value="0" />
5729         <max value="1" />
5730       </base>
5731       <type>
5732         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
5733           <valueUrl value="string" />
5734         </extension>
5735         <code value="http://hl7.org/fhirpath/System.String" />
5736       </type>
5737       <condition value="ele-1" />
5738       <isModifier value="false" />
5739       <isSummary value="false" />
5740       <mapping>
5741         <identity value="rim" />
5742         <map value="n/a" />
5743       </mapping>
5744     </element>
5745     <element id="DeviceDefinition.link.extension">
5746       <path value="DeviceDefinition.link.extension" />
5747       <short value="Additional content defined by implementations" />
5748       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
5749       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
5750       <alias value="extensions" />
5751       <alias value="user content" />
5752       <min value="0" />
5753       <max value="*" />
5754       <base>
5755         <path value="Element.extension" />
5756         <min value="0" />
5757         <max value="*" />
5758       </base>
5759       <type>
5760         <code value="Extension" />
5761       </type>
5762       <constraint>
5763         <key value="ele-1" />
5764         <severity value="error" />
5765         <human value="All FHIR elements must have a @value or children" />
5766         <expression value="hasValue() or (children().count() > id.count())" />
5767         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5768       </constraint>
5769       <constraint>
5770         <key value="ext-1" />
5771         <severity value="error" />
5772         <human value="Must have either extensions or value[x], not both" />
5773         <expression value="extension.exists() != value.exists()" />
5774         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
5775       </constraint>
5776       <isModifier value="false" />
5777       <isSummary value="false" />
5778       <mapping>
5779         <identity value="rim" />
5780         <map value="n/a" />
5781       </mapping>
5782     </element>
5783     <element id="DeviceDefinition.link.modifierExtension">
5784       <path value="DeviceDefinition.link.modifierExtension" />
5785       <short value="Extensions that cannot be ignored even if unrecognized" />
5786       <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
5787       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
5788       <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)." />
5789       <alias value="extensions" />
5790       <alias value="user content" />
5791       <alias value="modifiers" />
5792       <min value="0" />
5793       <max value="*" />
5794       <base>
5795         <path value="BackboneElement.modifierExtension" />
5796         <min value="0" />
5797         <max value="*" />
5798       </base>
5799       <type>
5800         <code value="Extension" />
5801       </type>
5802       <constraint>
5803         <key value="ele-1" />
5804         <severity value="error" />
5805         <human value="All FHIR elements must have a @value or children" />
5806         <expression value="hasValue() or (children().count() > id.count())" />
5807         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5808       </constraint>
5809       <constraint>
5810         <key value="ext-1" />
5811         <severity value="error" />
5812         <human value="Must have either extensions or value[x], not both" />
5813         <expression value="extension.exists() != value.exists()" />
5814         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
5815       </constraint>
5816       <isModifier value="true" />
5817       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
5818       <isSummary value="true" />
5819       <mapping>
5820         <identity value="rim" />
5821         <map value="N/A" />
5822       </mapping>
5823     </element>
5824     <element id="DeviceDefinition.link.relation">
5825       <path value="DeviceDefinition.link.relation" />
5826       <short value="The type indicates the relationship of the related device to the device instance" />
5827       <definition value="The type indicates the relationship of the related device to the device instance." />
5828       <min value="1" />
5829       <max value="1" />
5830       <base>
5831         <path value="DeviceDefinition.link.relation" />
5832         <min value="1" />
5833         <max value="1" />
5834       </base>
5835       <type>
5836         <code value="Coding" />
5837       </type>
5838       <constraint>
5839         <key value="ele-1" />
5840         <severity value="error" />
5841         <human value="All FHIR elements must have a @value or children" />
5842         <expression value="hasValue() or (children().count() > id.count())" />
5843         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5844       </constraint>
5845       <mustSupport value="false" />
5846       <isModifier value="false" />
5847       <isSummary value="false" />
5848       <binding>
5849         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
5850           <valueString value="DeviceDefinitionRelationType" />
5851         </extension>
5852         <strength value="extensible" />
5853         <description value="The type of relation between this and the linked device." />
5854         <valueSet value="http://hl7.org/fhir/ValueSet/devicedefinition-relationtype" />
5855       </binding>
5856     </element>
5857     <element id="DeviceDefinition.link.relatedDevice">
5858       <path value="DeviceDefinition.link.relatedDevice" />
5859       <short value="A reference to the linked device" />
5860       <definition value="A reference to the linked device." />
5861       <min value="1" />
5862       <max value="1" />
5863       <base>
5864         <path value="DeviceDefinition.link.relatedDevice" />
5865         <min value="1" />
5866         <max value="1" />
5867       </base>
5868       <type>
5869         <code value="CodeableReference" />
5870         <targetProfile value="http://hl7.org/fhir/StructureDefinition/DeviceDefinition" />
5871       </type>
5872       <constraint>
5873         <key value="ele-1" />
5874         <severity value="error" />
5875         <human value="All FHIR elements must have a @value or children" />
5876         <expression value="hasValue() or (children().count() > id.count())" />
5877         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5878       </constraint>
5879       <mustSupport value="false" />
5880       <isModifier value="false" />
5881       <isSummary value="false" />
5882     </element>
5883     <element id="DeviceDefinition.note">
5884       <path value="DeviceDefinition.note" />
5885       <short value="Device notes and comments" />
5886       <definition value="Descriptive information, usage information or implantation information that is not captured in an existing element." />
5887       <min value="0" />
5888       <max value="*" />
5889       <base>
5890         <path value="DeviceDefinition.note" />
5891         <min value="0" />
5892         <max value="*" />
5893       </base>
5894       <type>
5895         <code value="Annotation" />
5896       </type>
5897       <constraint>
5898         <key value="ele-1" />
5899         <severity value="error" />
5900         <human value="All FHIR elements must have a @value or children" />
5901         <expression value="hasValue() or (children().count() > id.count())" />
5902         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5903       </constraint>
5904       <mustSupport value="false" />
5905       <isModifier value="false" />
5906       <isSummary value="false" />
5907       <mapping>
5908         <identity value="rim" />
5909         <map value=".text" />
5910       </mapping>
5911     </element>
5912     <element id="DeviceDefinition.material">
5913       <path value="DeviceDefinition.material" />
5914       <short value="A substance used to create the material(s) of which the device is made" />
5915       <definition value="A substance used to create the material(s) of which the device is made." />
5916       <min value="0" />
5917       <max value="*" />
5918       <base>
5919         <path value="DeviceDefinition.material" />
5920         <min value="0" />
5921         <max value="*" />
5922       </base>
5923       <type>
5924         <code value="BackboneElement" />
5925       </type>
5926       <constraint>
5927         <key value="ele-1" />
5928         <severity value="error" />
5929         <human value="All FHIR elements must have a @value or children" />
5930         <expression value="hasValue() or (children().count() > id.count())" />
5931         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5932       </constraint>
5933       <mustSupport value="false" />
5934       <isModifier value="false" />
5935       <isSummary value="false" />
5936     </element>
5937     <element id="DeviceDefinition.material.id">
5938       <path value="DeviceDefinition.material.id" />
5939       <representation value="xmlAttr" />
5940       <short value="Unique id for inter-element referencing" />
5941       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
5942       <min value="0" />
5943       <max value="1" />
5944       <base>
5945         <path value="Element.id" />
5946         <min value="0" />
5947         <max value="1" />
5948       </base>
5949       <type>
5950         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
5951           <valueUrl value="string" />
5952         </extension>
5953         <code value="http://hl7.org/fhirpath/System.String" />
5954       </type>
5955       <condition value="ele-1" />
5956       <isModifier value="false" />
5957       <isSummary value="false" />
5958       <mapping>
5959         <identity value="rim" />
5960         <map value="n/a" />
5961       </mapping>
5962     </element>
5963     <element id="DeviceDefinition.material.extension">
5964       <path value="DeviceDefinition.material.extension" />
5965       <short value="Additional content defined by implementations" />
5966       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
5967       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
5968       <alias value="extensions" />
5969       <alias value="user content" />
5970       <min value="0" />
5971       <max value="*" />
5972       <base>
5973         <path value="Element.extension" />
5974         <min value="0" />
5975         <max value="*" />
5976       </base>
5977       <type>
5978         <code value="Extension" />
5979       </type>
5980       <constraint>
5981         <key value="ele-1" />
5982         <severity value="error" />
5983         <human value="All FHIR elements must have a @value or children" />
5984         <expression value="hasValue() or (children().count() > id.count())" />
5985         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
5986       </constraint>
5987       <constraint>
5988         <key value="ext-1" />
5989         <severity value="error" />
5990         <human value="Must have either extensions or value[x], not both" />
5991         <expression value="extension.exists() != value.exists()" />
5992         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
5993       </constraint>
5994       <isModifier value="false" />
5995       <isSummary value="false" />
5996       <mapping>
5997         <identity value="rim" />
5998         <map value="n/a" />
5999       </mapping>
6000     </element>
6001     <element id="DeviceDefinition.material.modifierExtension">
6002       <path value="DeviceDefinition.material.modifierExtension" />
6003       <short value="Extensions that cannot be ignored even if unrecognized" />
6004       <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
6005       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
6006       <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)." />
6007       <alias value="extensions" />
6008       <alias value="user content" />
6009       <alias value="modifiers" />
6010       <min value="0" />
6011       <max value="*" />
6012       <base>
6013         <path value="BackboneElement.modifierExtension" />
6014         <min value="0" />
6015         <max value="*" />
6016       </base>
6017       <type>
6018         <code value="Extension" />
6019       </type>
6020       <constraint>
6021         <key value="ele-1" />
6022         <severity value="error" />
6023         <human value="All FHIR elements must have a @value or children" />
6024         <expression value="hasValue() or (children().count() > id.count())" />
6025         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6026       </constraint>
6027       <constraint>
6028         <key value="ext-1" />
6029         <severity value="error" />
6030         <human value="Must have either extensions or value[x], not both" />
6031         <expression value="extension.exists() != value.exists()" />
6032         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
6033       </constraint>
6034       <isModifier value="true" />
6035       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
6036       <isSummary value="true" />
6037       <mapping>
6038         <identity value="rim" />
6039         <map value="N/A" />
6040       </mapping>
6041     </element>
6042     <element id="DeviceDefinition.material.substance">
6043       <path value="DeviceDefinition.material.substance" />
6044       <short value="A relevant substance that the device contains, may contain, or is made of" />
6045       <definition value="A substance that the device contains, may contain, or is made of - for example latex - to be used to determine patient compatibility. This is not intended to represent the composition of the device, only the clinically relevant materials." />
6046       <min value="1" />
6047       <max value="1" />
6048       <base>
6049         <path value="DeviceDefinition.material.substance" />
6050         <min value="1" />
6051         <max value="1" />
6052       </base>
6053       <type>
6054         <code value="CodeableConcept" />
6055       </type>
6056       <constraint>
6057         <key value="ele-1" />
6058         <severity value="error" />
6059         <human value="All FHIR elements must have a @value or children" />
6060         <expression value="hasValue() or (children().count() > id.count())" />
6061         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6062       </constraint>
6063       <mustSupport value="false" />
6064       <isModifier value="false" />
6065       <isSummary value="false" />
6066     </element>
6067     <element id="DeviceDefinition.material.alternate">
6068       <path value="DeviceDefinition.material.alternate" />
6069       <short value="Indicates an alternative material of the device" />
6070       <definition value="Indicates an alternative material of the device." />
6071       <min value="0" />
6072       <max value="1" />
6073       <base>
6074         <path value="DeviceDefinition.material.alternate" />
6075         <min value="0" />
6076         <max value="1" />
6077       </base>
6078       <type>
6079         <code value="boolean" />
6080       </type>
6081       <constraint>
6082         <key value="ele-1" />
6083         <severity value="error" />
6084         <human value="All FHIR elements must have a @value or children" />
6085         <expression value="hasValue() or (children().count() > id.count())" />
6086         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6087       </constraint>
6088       <mustSupport value="false" />
6089       <isModifier value="false" />
6090       <isSummary value="false" />
6091     </element>
6092     <element id="DeviceDefinition.material.allergenicIndicator">
6093       <path value="DeviceDefinition.material.allergenicIndicator" />
6094       <short value="Whether the substance is a known or suspected allergen" />
6095       <definition value="Whether the substance is a known or suspected allergen." />
6096       <min value="0" />
6097       <max value="1" />
6098       <base>
6099         <path value="DeviceDefinition.material.allergenicIndicator" />
6100         <min value="0" />
6101         <max value="1" />
6102       </base>
6103       <type>
6104         <code value="boolean" />
6105       </type>
6106       <constraint>
6107         <key value="ele-1" />
6108         <severity value="error" />
6109         <human value="All FHIR elements must have a @value or children" />
6110         <expression value="hasValue() or (children().count() > id.count())" />
6111         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6112       </constraint>
6113       <mustSupport value="false" />
6114       <isModifier value="false" />
6115       <isSummary value="false" />
6116     </element>
6117     <element id="DeviceDefinition.productionIdentifierInUDI">
6118       <path value="DeviceDefinition.productionIdentifierInUDI" />
6119       <short value="lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version" />
6120       <definition value="Indicates the production identifier(s) that are expected to appear in the UDI carrier on the device label." />
6121       <min value="0" />
6122       <max value="*" />
6123       <base>
6124         <path value="DeviceDefinition.productionIdentifierInUDI" />
6125         <min value="0" />
6126         <max value="*" />
6127       </base>
6128       <type>
6129         <code value="code" />
6130       </type>
6131       <constraint>
6132         <key value="ele-1" />
6133         <severity value="error" />
6134         <human value="All FHIR elements must have a @value or children" />
6135         <expression value="hasValue() or (children().count() > id.count())" />
6136         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6137       </constraint>
6138       <mustSupport value="false" />
6139       <isModifier value="false" />
6140       <isSummary value="false" />
6141       <binding>
6142         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
6143           <valueString value="DeviceProductionIdentifierInUDI" />
6144         </extension>
6145         <strength value="required" />
6146         <description value="The production identifier(s) that are expected to appear in the UDI carrier." />
6147         <valueSet value="http://hl7.org/fhir/ValueSet/device-productidentifierinudi|5.0.0" />
6148       </binding>
6149       <mapping>
6150         <identity value="devicedefinition-to-gudid" />
6151         <map value="PRODUCTION IDENTIFIER(S) IN UDI" />
6152       </mapping>
6153     </element>
6154     <element id="DeviceDefinition.guideline">
6155       <path value="DeviceDefinition.guideline" />
6156       <short value="Information aimed at providing directions for the usage of this model of device" />
6157       <definition value="Information aimed at providing directions for the usage of this model of device." />
6158       <comment value="For more structured data, a ClinicalUseDefinition that points to the DeviceDefinition can be used." />
6159       <min value="0" />
6160       <max value="1" />
6161       <base>
6162         <path value="DeviceDefinition.guideline" />
6163         <min value="0" />
6164         <max value="1" />
6165       </base>
6166       <type>
6167         <code value="BackboneElement" />
6168       </type>
6169       <constraint>
6170         <key value="ele-1" />
6171         <severity value="error" />
6172         <human value="All FHIR elements must have a @value or children" />
6173         <expression value="hasValue() or (children().count() > id.count())" />
6174         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6175       </constraint>
6176       <mustSupport value="true" />
6177       <isModifier value="false" />
6178       <isSummary value="false" />
6179     </element>
6180     <element id="DeviceDefinition.guideline.id">
6181       <path value="DeviceDefinition.guideline.id" />
6182       <representation value="xmlAttr" />
6183       <short value="Unique id for inter-element referencing" />
6184       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
6185       <min value="0" />
6186       <max value="1" />
6187       <base>
6188         <path value="Element.id" />
6189         <min value="0" />
6190         <max value="1" />
6191       </base>
6192       <type>
6193         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
6194           <valueUrl value="string" />
6195         </extension>
6196         <code value="http://hl7.org/fhirpath/System.String" />
6197       </type>
6198       <condition value="ele-1" />
6199       <isModifier value="false" />
6200       <isSummary value="false" />
6201       <mapping>
6202         <identity value="rim" />
6203         <map value="n/a" />
6204       </mapping>
6205     </element>
6206     <element id="DeviceDefinition.guideline.extension">
6207       <path value="DeviceDefinition.guideline.extension" />
6208       <short value="Additional content defined by implementations" />
6209       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
6210       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
6211       <alias value="extensions" />
6212       <alias value="user content" />
6213       <min value="0" />
6214       <max value="*" />
6215       <base>
6216         <path value="Element.extension" />
6217         <min value="0" />
6218         <max value="*" />
6219       </base>
6220       <type>
6221         <code value="Extension" />
6222       </type>
6223       <constraint>
6224         <key value="ele-1" />
6225         <severity value="error" />
6226         <human value="All FHIR elements must have a @value or children" />
6227         <expression value="hasValue() or (children().count() > id.count())" />
6228         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6229       </constraint>
6230       <constraint>
6231         <key value="ext-1" />
6232         <severity value="error" />
6233         <human value="Must have either extensions or value[x], not both" />
6234         <expression value="extension.exists() != value.exists()" />
6235         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
6236       </constraint>
6237       <isModifier value="false" />
6238       <isSummary value="false" />
6239       <mapping>
6240         <identity value="rim" />
6241         <map value="n/a" />
6242       </mapping>
6243     </element>
6244     <element id="DeviceDefinition.guideline.modifierExtension">
6245       <path value="DeviceDefinition.guideline.modifierExtension" />
6246       <short value="Extensions that cannot be ignored even if unrecognized" />
6247       <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
6248       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
6249       <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)." />
6250       <alias value="extensions" />
6251       <alias value="user content" />
6252       <alias value="modifiers" />
6253       <min value="0" />
6254       <max value="*" />
6255       <base>
6256         <path value="BackboneElement.modifierExtension" />
6257         <min value="0" />
6258         <max value="*" />
6259       </base>
6260       <type>
6261         <code value="Extension" />
6262       </type>
6263       <constraint>
6264         <key value="ele-1" />
6265         <severity value="error" />
6266         <human value="All FHIR elements must have a @value or children" />
6267         <expression value="hasValue() or (children().count() > id.count())" />
6268         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6269       </constraint>
6270       <constraint>
6271         <key value="ext-1" />
6272         <severity value="error" />
6273         <human value="Must have either extensions or value[x], not both" />
6274         <expression value="extension.exists() != value.exists()" />
6275         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
6276       </constraint>
6277       <isModifier value="true" />
6278       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
6279       <isSummary value="true" />
6280       <mapping>
6281         <identity value="rim" />
6282         <map value="N/A" />
6283       </mapping>
6284     </element>
6285     <element id="DeviceDefinition.guideline.useContext">
6286       <path value="DeviceDefinition.guideline.useContext" />
6287       <short value="The circumstances that form the setting for using the device" />
6288       <definition value="The circumstances that form the setting for using the device." />
6289       <min value="0" />
6290       <max value="*" />
6291       <base>
6292         <path value="DeviceDefinition.guideline.useContext" />
6293         <min value="0" />
6294         <max value="*" />
6295       </base>
6296       <type>
6297         <code value="UsageContext" />
6298       </type>
6299       <constraint>
6300         <key value="ele-1" />
6301         <severity value="error" />
6302         <human value="All FHIR elements must have a @value or children" />
6303         <expression value="hasValue() or (children().count() > id.count())" />
6304         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6305       </constraint>
6306       <mustSupport value="false" />
6307       <isModifier value="false" />
6308       <isSummary value="false" />
6309     </element>
6310     <element id="DeviceDefinition.guideline.usageInstruction">
6311       <path value="DeviceDefinition.guideline.usageInstruction" />
6312       <short value="Detailed written and visual directions for the user on how to use the device" />
6313       <definition value="Detailed written and visual directions for the user on how to use the device." />
6314       <min value="0" />
6315       <max value="1" />
6316       <base>
6317         <path value="DeviceDefinition.guideline.usageInstruction" />
6318         <min value="0" />
6319         <max value="1" />
6320       </base>
6321       <type>
6322         <code value="markdown" />
6323       </type>
6324       <constraint>
6325         <key value="ele-1" />
6326         <severity value="error" />
6327         <human value="All FHIR elements must have a @value or children" />
6328         <expression value="hasValue() or (children().count() > id.count())" />
6329         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6330       </constraint>
6331       <mustSupport value="false" />
6332       <isModifier value="false" />
6333       <isSummary value="false" />
6334     </element>
6335     <element id="DeviceDefinition.guideline.relatedArtifact">
6336       <path value="DeviceDefinition.guideline.relatedArtifact" />
6337       <short value="A source of information or reference for this guideline" />
6338       <definition value="A source of information or reference for this guideline." />
6339       <min value="0" />
6340       <max value="*" />
6341       <base>
6342         <path value="DeviceDefinition.guideline.relatedArtifact" />
6343         <min value="0" />
6344         <max value="*" />
6345       </base>
6346       <type>
6347         <code value="RelatedArtifact" />
6348       </type>
6349       <constraint>
6350         <key value="ele-1" />
6351         <severity value="error" />
6352         <human value="All FHIR elements must have a @value or children" />
6353         <expression value="hasValue() or (children().count() > id.count())" />
6354         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6355       </constraint>
6356       <mustSupport value="false" />
6357       <isModifier value="false" />
6358       <isSummary value="false" />
6359     </element>
6360     <element id="DeviceDefinition.guideline.indication">
6361       <path value="DeviceDefinition.guideline.indication" />
6362       <short value="A clinical condition for which the device was designed to be used" />
6363       <definition value="A clinical condition for which the device was designed to be used." />
6364       <comment value="A ClinicalUseDefinition that points to the DeviceDefinition can be used if more structured data is needed." />
6365       <min value="0" />
6366       <max value="*" />
6367       <base>
6368         <path value="DeviceDefinition.guideline.indication" />
6369         <min value="0" />
6370         <max value="*" />
6371       </base>
6372       <type>
6373         <code value="CodeableConcept" />
6374       </type>
6375       <constraint>
6376         <key value="ele-1" />
6377         <severity value="error" />
6378         <human value="All FHIR elements must have a @value or children" />
6379         <expression value="hasValue() or (children().count() > id.count())" />
6380         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6381       </constraint>
6382       <mustSupport value="false" />
6383       <isModifier value="false" />
6384       <isSummary value="false" />
6385     </element>
6386     <element id="DeviceDefinition.guideline.contraindication">
6387       <path value="DeviceDefinition.guideline.contraindication" />
6388       <short value="A specific situation when a device should not be used because it may cause harm" />
6389       <definition value="A specific situation when a device should not be used because it may cause harm." />
6390       <comment value="A ClinicalUseDefinition that points to the DeviceDefinition can be used if more structured data is needed." />
6391       <min value="0" />
6392       <max value="*" />
6393       <base>
6394         <path value="DeviceDefinition.guideline.contraindication" />
6395         <min value="0" />
6396         <max value="*" />
6397       </base>
6398       <type>
6399         <code value="CodeableConcept" />
6400       </type>
6401       <constraint>
6402         <key value="ele-1" />
6403         <severity value="error" />
6404         <human value="All FHIR elements must have a @value or children" />
6405         <expression value="hasValue() or (children().count() > id.count())" />
6406         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6407       </constraint>
6408       <mustSupport value="false" />
6409       <isModifier value="false" />
6410       <isSummary value="false" />
6411     </element>
6412     <element id="DeviceDefinition.guideline.warning">
6413       <path value="DeviceDefinition.guideline.warning" />
6414       <short value="Specific hazard alert information that a user needs to know before using the device" />
6415       <definition value="Specific hazard alert information that a user needs to know before using the device." />
6416       <comment value="A ClinicalUseDefinition that points to the DeviceDefinition can be used if more structured data is needed." />
6417       <min value="0" />
6418       <max value="*" />
6419       <base>
6420         <path value="DeviceDefinition.guideline.warning" />
6421         <min value="0" />
6422         <max value="*" />
6423       </base>
6424       <type>
6425         <code value="CodeableConcept" />
6426       </type>
6427       <constraint>
6428         <key value="ele-1" />
6429         <severity value="error" />
6430         <human value="All FHIR elements must have a @value or children" />
6431         <expression value="hasValue() or (children().count() > id.count())" />
6432         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6433       </constraint>
6434       <mustSupport value="false" />
6435       <isModifier value="false" />
6436       <isSummary value="false" />
6437     </element>
6438     <element id="DeviceDefinition.guideline.intendedUse">
6439       <path value="DeviceDefinition.guideline.intendedUse" />
6440       <short value="A description of the general purpose or medical use of the device or its function" />
6441       <definition value="A description of the general purpose or medical use of the device or its function." />
6442       <min value="0" />
6443       <max value="1" />
6444       <base>
6445         <path value="DeviceDefinition.guideline.intendedUse" />
6446         <min value="0" />
6447         <max value="1" />
6448       </base>
6449       <type>
6450         <code value="string" />
6451       </type>
6452       <constraint>
6453         <key value="ele-1" />
6454         <severity value="error" />
6455         <human value="All FHIR elements must have a @value or children" />
6456         <expression value="hasValue() or (children().count() > id.count())" />
6457         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6458       </constraint>
6459       <mustSupport value="false" />
6460       <isModifier value="false" />
6461       <isSummary value="false" />
6462     </element>
6463     <element id="DeviceDefinition.correctiveAction">
6464       <path value="DeviceDefinition.correctiveAction" />
6465       <short value="Tracking of latest field safety corrective action" />
6466       <definition value="Tracking of latest field safety corrective action." />
6467       <min value="0" />
6468       <max value="1" />
6469       <base>
6470         <path value="DeviceDefinition.correctiveAction" />
6471         <min value="0" />
6472         <max value="1" />
6473       </base>
6474       <type>
6475         <code value="BackboneElement" />
6476       </type>
6477       <constraint>
6478         <key value="ele-1" />
6479         <severity value="error" />
6480         <human value="All FHIR elements must have a @value or children" />
6481         <expression value="hasValue() or (children().count() > id.count())" />
6482         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6483       </constraint>
6484       <mustSupport value="false" />
6485       <isModifier value="false" />
6486       <isSummary value="false" />
6487     </element>
6488     <element id="DeviceDefinition.correctiveAction.id">
6489       <path value="DeviceDefinition.correctiveAction.id" />
6490       <representation value="xmlAttr" />
6491       <short value="Unique id for inter-element referencing" />
6492       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
6493       <min value="0" />
6494       <max value="1" />
6495       <base>
6496         <path value="Element.id" />
6497         <min value="0" />
6498         <max value="1" />
6499       </base>
6500       <type>
6501         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
6502           <valueUrl value="string" />
6503         </extension>
6504         <code value="http://hl7.org/fhirpath/System.String" />
6505       </type>
6506       <condition value="ele-1" />
6507       <isModifier value="false" />
6508       <isSummary value="false" />
6509       <mapping>
6510         <identity value="rim" />
6511         <map value="n/a" />
6512       </mapping>
6513     </element>
6514     <element id="DeviceDefinition.correctiveAction.extension">
6515       <path value="DeviceDefinition.correctiveAction.extension" />
6516       <short value="Additional content defined by implementations" />
6517       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
6518       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
6519       <alias value="extensions" />
6520       <alias value="user content" />
6521       <min value="0" />
6522       <max value="*" />
6523       <base>
6524         <path value="Element.extension" />
6525         <min value="0" />
6526         <max value="*" />
6527       </base>
6528       <type>
6529         <code value="Extension" />
6530       </type>
6531       <constraint>
6532         <key value="ele-1" />
6533         <severity value="error" />
6534         <human value="All FHIR elements must have a @value or children" />
6535         <expression value="hasValue() or (children().count() > id.count())" />
6536         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6537       </constraint>
6538       <constraint>
6539         <key value="ext-1" />
6540         <severity value="error" />
6541         <human value="Must have either extensions or value[x], not both" />
6542         <expression value="extension.exists() != value.exists()" />
6543         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
6544       </constraint>
6545       <isModifier value="false" />
6546       <isSummary value="false" />
6547       <mapping>
6548         <identity value="rim" />
6549         <map value="n/a" />
6550       </mapping>
6551     </element>
6552     <element id="DeviceDefinition.correctiveAction.modifierExtension">
6553       <path value="DeviceDefinition.correctiveAction.modifierExtension" />
6554       <short value="Extensions that cannot be ignored even if unrecognized" />
6555       <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
6556       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
6557       <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)." />
6558       <alias value="extensions" />
6559       <alias value="user content" />
6560       <alias value="modifiers" />
6561       <min value="0" />
6562       <max value="*" />
6563       <base>
6564         <path value="BackboneElement.modifierExtension" />
6565         <min value="0" />
6566         <max value="*" />
6567       </base>
6568       <type>
6569         <code value="Extension" />
6570       </type>
6571       <constraint>
6572         <key value="ele-1" />
6573         <severity value="error" />
6574         <human value="All FHIR elements must have a @value or children" />
6575         <expression value="hasValue() or (children().count() > id.count())" />
6576         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6577       </constraint>
6578       <constraint>
6579         <key value="ext-1" />
6580         <severity value="error" />
6581         <human value="Must have either extensions or value[x], not both" />
6582         <expression value="extension.exists() != value.exists()" />
6583         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
6584       </constraint>
6585       <isModifier value="true" />
6586       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
6587       <isSummary value="true" />
6588       <mapping>
6589         <identity value="rim" />
6590         <map value="N/A" />
6591       </mapping>
6592     </element>
6593     <element id="DeviceDefinition.correctiveAction.recall">
6594       <path value="DeviceDefinition.correctiveAction.recall" />
6595       <short value="Whether the corrective action was a recall" />
6596       <definition value="Whether the last corrective action known for this device was a recall." />
6597       <comment value="When a field safety action has been initiated but not yet resulted in a recall, this element will be set to 'false'." />
6598       <min value="1" />
6599       <max value="1" />
6600       <base>
6601         <path value="DeviceDefinition.correctiveAction.recall" />
6602         <min value="1" />
6603         <max value="1" />
6604       </base>
6605       <type>
6606         <code value="boolean" />
6607       </type>
6608       <constraint>
6609         <key value="ele-1" />
6610         <severity value="error" />
6611         <human value="All FHIR elements must have a @value or children" />
6612         <expression value="hasValue() or (children().count() > id.count())" />
6613         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6614       </constraint>
6615       <mustSupport value="false" />
6616       <isModifier value="false" />
6617       <isSummary value="false" />
6618     </element>
6619     <element id="DeviceDefinition.correctiveAction.scope">
6620       <path value="DeviceDefinition.correctiveAction.scope" />
6621       <short value="model | lot-numbers | serial-numbers" />
6622       <definition value="The scope of the corrective action - whether the action targeted all units of a given device model, or only a specific set of batches identified by lot numbers, or individually identified devices identified by the serial name." />
6623       <min value="0" />
6624       <max value="1" />
6625       <base>
6626         <path value="DeviceDefinition.correctiveAction.scope" />
6627         <min value="0" />
6628         <max value="1" />
6629       </base>
6630       <type>
6631         <code value="code" />
6632       </type>
6633       <constraint>
6634         <key value="ele-1" />
6635         <severity value="error" />
6636         <human value="All FHIR elements must have a @value or children" />
6637         <expression value="hasValue() or (children().count() > id.count())" />
6638         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6639       </constraint>
6640       <mustSupport value="false" />
6641       <isModifier value="false" />
6642       <isSummary value="false" />
6643       <binding>
6644         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
6645           <valueString value="DeviceCorrectiveActionScope" />
6646         </extension>
6647         <strength value="required" />
6648         <description value="The type or scope of the corrective action." />
6649         <valueSet value="http://hl7.org/fhir/ValueSet/device-correctiveactionscope|5.0.0" />
6650       </binding>
6651     </element>
6652     <element id="DeviceDefinition.correctiveAction.period">
6653       <path value="DeviceDefinition.correctiveAction.period" />
6654       <short value="Start and end dates of the  corrective action" />
6655       <definition value="Start and end dates of the  corrective action." />
6656       <min value="1" />
6657       <max value="1" />
6658       <base>
6659         <path value="DeviceDefinition.correctiveAction.period" />
6660         <min value="1" />
6661         <max value="1" />
6662       </base>
6663       <type>
6664         <code value="Period" />
6665       </type>
6666       <constraint>
6667         <key value="ele-1" />
6668         <severity value="error" />
6669         <human value="All FHIR elements must have a @value or children" />
6670         <expression value="hasValue() or (children().count() > id.count())" />
6671         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6672       </constraint>
6673       <mustSupport value="false" />
6674       <isModifier value="false" />
6675       <isSummary value="false" />
6676     </element>
6677     <element id="DeviceDefinition.chargeItem">
6678       <path value="DeviceDefinition.chargeItem" />
6679       <short value="Billing code or reference associated with the device" />
6680       <definition value="Billing code or reference associated with the device." />
6681       <min value="0" />
6682       <max value="*" />
6683       <base>
6684         <path value="DeviceDefinition.chargeItem" />
6685         <min value="0" />
6686         <max value="*" />
6687       </base>
6688       <type>
6689         <code value="BackboneElement" />
6690       </type>
6691       <constraint>
6692         <key value="ele-1" />
6693         <severity value="error" />
6694         <human value="All FHIR elements must have a @value or children" />
6695         <expression value="hasValue() or (children().count() > id.count())" />
6696         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6697       </constraint>
6698       <mustSupport value="false" />
6699       <isModifier value="false" />
6700       <isSummary value="false" />
6701     </element>
6702     <element id="DeviceDefinition.chargeItem.id">
6703       <path value="DeviceDefinition.chargeItem.id" />
6704       <representation value="xmlAttr" />
6705       <short value="Unique id for inter-element referencing" />
6706       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
6707       <min value="0" />
6708       <max value="1" />
6709       <base>
6710         <path value="Element.id" />
6711         <min value="0" />
6712         <max value="1" />
6713       </base>
6714       <type>
6715         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
6716           <valueUrl value="string" />
6717         </extension>
6718         <code value="http://hl7.org/fhirpath/System.String" />
6719       </type>
6720       <condition value="ele-1" />
6721       <isModifier value="false" />
6722       <isSummary value="false" />
6723       <mapping>
6724         <identity value="rim" />
6725         <map value="n/a" />
6726       </mapping>
6727     </element>
6728     <element id="DeviceDefinition.chargeItem.extension">
6729       <path value="DeviceDefinition.chargeItem.extension" />
6730       <short value="Additional content defined by implementations" />
6731       <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
6732       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
6733       <alias value="extensions" />
6734       <alias value="user content" />
6735       <min value="0" />
6736       <max value="*" />
6737       <base>
6738         <path value="Element.extension" />
6739         <min value="0" />
6740         <max value="*" />
6741       </base>
6742       <type>
6743         <code value="Extension" />
6744       </type>
6745       <constraint>
6746         <key value="ele-1" />
6747         <severity value="error" />
6748         <human value="All FHIR elements must have a @value or children" />
6749         <expression value="hasValue() or (children().count() > id.count())" />
6750         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6751       </constraint>
6752       <constraint>
6753         <key value="ext-1" />
6754         <severity value="error" />
6755         <human value="Must have either extensions or value[x], not both" />
6756         <expression value="extension.exists() != value.exists()" />
6757         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
6758       </constraint>
6759       <isModifier value="false" />
6760       <isSummary value="false" />
6761       <mapping>
6762         <identity value="rim" />
6763         <map value="n/a" />
6764       </mapping>
6765     </element>
6766     <element id="DeviceDefinition.chargeItem.modifierExtension">
6767       <path value="DeviceDefinition.chargeItem.modifierExtension" />
6768       <short value="Extensions that cannot be ignored even if unrecognized" />
6769       <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
6770       <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
6771       <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)." />
6772       <alias value="extensions" />
6773       <alias value="user content" />
6774       <alias value="modifiers" />
6775       <min value="0" />
6776       <max value="*" />
6777       <base>
6778         <path value="BackboneElement.modifierExtension" />
6779         <min value="0" />
6780         <max value="*" />
6781       </base>
6782       <type>
6783         <code value="Extension" />
6784       </type>
6785       <constraint>
6786         <key value="ele-1" />
6787         <severity value="error" />
6788         <human value="All FHIR elements must have a @value or children" />
6789         <expression value="hasValue() or (children().count() > id.count())" />
6790         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6791       </constraint>
6792       <constraint>
6793         <key value="ext-1" />
6794         <severity value="error" />
6795         <human value="Must have either extensions or value[x], not both" />
6796         <expression value="extension.exists() != value.exists()" />
6797         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
6798       </constraint>
6799       <isModifier value="true" />
6800       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
6801       <isSummary value="true" />
6802       <mapping>
6803         <identity value="rim" />
6804         <map value="N/A" />
6805       </mapping>
6806     </element>
6807     <element id="DeviceDefinition.chargeItem.chargeItemCode">
6808       <path value="DeviceDefinition.chargeItem.chargeItemCode" />
6809       <short value="The code or reference for the charge item" />
6810       <definition value="The code or reference for the charge item." />
6811       <min value="1" />
6812       <max value="1" />
6813       <base>
6814         <path value="DeviceDefinition.chargeItem.chargeItemCode" />
6815         <min value="1" />
6816         <max value="1" />
6817       </base>
6818       <type>
6819         <code value="CodeableReference" />
6820         <targetProfile value="http://hl7.org/fhir/StructureDefinition/ChargeItemDefinition" />
6821       </type>
6822       <constraint>
6823         <key value="ele-1" />
6824         <severity value="error" />
6825         <human value="All FHIR elements must have a @value or children" />
6826         <expression value="hasValue() or (children().count() > id.count())" />
6827         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6828       </constraint>
6829       <mustSupport value="false" />
6830       <isModifier value="false" />
6831       <isSummary value="false" />
6832     </element>
6833     <element id="DeviceDefinition.chargeItem.count">
6834       <path value="DeviceDefinition.chargeItem.count" />
6835       <short value="Coefficient applicable to the billing code" />
6836       <definition value="Coefficient applicable to the billing code." />
6837       <min value="1" />
6838       <max value="1" />
6839       <base>
6840         <path value="DeviceDefinition.chargeItem.count" />
6841         <min value="1" />
6842         <max value="1" />
6843       </base>
6844       <type>
6845         <code value="Quantity" />
6846       </type>
6847       <constraint>
6848         <key value="ele-1" />
6849         <severity value="error" />
6850         <human value="All FHIR elements must have a @value or children" />
6851         <expression value="hasValue() or (children().count() > id.count())" />
6852         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6853       </constraint>
6854       <mustSupport value="false" />
6855       <isModifier value="false" />
6856       <isSummary value="false" />
6857     </element>
6858     <element id="DeviceDefinition.chargeItem.effectivePeriod">
6859       <path value="DeviceDefinition.chargeItem.effectivePeriod" />
6860       <short value="A specific time period in which this charge item applies" />
6861       <definition value="A specific time period in which this charge item applies." />
6862       <min value="0" />
6863       <max value="1" />
6864       <base>
6865         <path value="DeviceDefinition.chargeItem.effectivePeriod" />
6866         <min value="0" />
6867         <max value="1" />
6868       </base>
6869       <type>
6870         <code value="Period" />
6871       </type>
6872       <constraint>
6873         <key value="ele-1" />
6874         <severity value="error" />
6875         <human value="All FHIR elements must have a @value or children" />
6876         <expression value="hasValue() or (children().count() > id.count())" />
6877         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6878       </constraint>
6879       <mustSupport value="false" />
6880       <isModifier value="false" />
6881       <isSummary value="false" />
6882     </element>
6883     <element id="DeviceDefinition.chargeItem.useContext">
6884       <path value="DeviceDefinition.chargeItem.useContext" />
6885       <short value="The context to which this charge item applies" />
6886       <definition value="The context to which this charge item applies." />
6887       <min value="0" />
6888       <max value="*" />
6889       <base>
6890         <path value="DeviceDefinition.chargeItem.useContext" />
6891         <min value="0" />
6892         <max value="*" />
6893       </base>
6894       <type>
6895         <code value="UsageContext" />
6896       </type>
6897       <constraint>
6898         <key value="ele-1" />
6899         <severity value="error" />
6900         <human value="All FHIR elements must have a @value or children" />
6901         <expression value="hasValue() or (children().count() > id.count())" />
6902         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
6903       </constraint>
6904       <mustSupport value="false" />
6905       <isModifier value="false" />
6906       <isSummary value="false" />
6907     </element>
6908   </snapshot>
6909   <differential>
6910     <element id="DeviceDefinition">
6911       <path value="DeviceDefinition" />
6912       <mapping>
6913         <identity value="devicedefinition-to-eudamed" />
6914         <map value="EUDAMED data dictionary field IDs/labels" />
6915       </mapping>
6916       <mapping>
6917         <identity value="devicedefinition-to-gudid" />
6918         <map value="AccessGUDID section titles and field labels" />
6919       </mapping>
6920     </element>
6921     <element id="DeviceDefinition.extension">
6922       <path value="DeviceDefinition.extension" />
6923       <slicing>
6924         <discriminator>
6925           <type value="value" />
6926           <path value="url" />
6927         </discriminator>
6928         <ordered value="false" />
6929         <rules value="open" />
6930       </slicing>
6931     </element>
6932     <element id="DeviceDefinition.extension:CatalogReference">
6933       <path value="DeviceDefinition.extension" />
6934       <sliceName value="CatalogReference" />
6935       <min value="0" />
6936       <max value="*" />
6937       <type>
6938         <code value="Extension" />
6939         <profile value="http://hl7.org/fhir/uv/order-catalog/StructureDefinition/CatalogReference" />
6940       </type>
6941     </element>
6942     <element id="DeviceDefinition.description">
6943       <path value="DeviceDefinition.description" />
6944       <mustSupport value="true" />
6945       <mapping>
6946         <identity value="devicedefinition-to-eudamed" />
6947         <map value="FLD-UDID-175|Additional product description" />
6948       </mapping>
6949       <mapping>
6950         <identity value="devicedefinition-to-gudid" />
6951         <map value="Device Description" />
6952       </mapping>
6953     </element>
6954     <element id="DeviceDefinition.identifier">
6955       <path value="DeviceDefinition.identifier" />
6956       <definition value="This repeatable element is used in catalogs of devices to convey any kind of identifier assigned to the model of device, other than the primary UDI DI.
identifier may convey for instance, the secondary UDI-DI, the direct-marking UDI-DI, the unit-of-use UDI-DI or any additional non-UDI identifier." />
6957       <mustSupport value="true" />
6958       <mapping>
6959         <identity value="devicedefinition-to-eudamed" />
6960         <map value="FLD-UDID-136|Secondary UDI - DI code [use = secondary, type = DISTID]; FLD-UDID-138|Direct Marking UDI-DI code [type = DIRECT-MARKING]; FLD-UDID-135|Unit of Use DI code [type = SINGLE-ITEM]" />
6961       </mapping>
6962       <mapping>
6963         <identity value="devicedefinition-to-gudid" />
6964         <map value="Secondary DI Number [use = secondary, type = DISTID]; DM DI Number [type = DIRECT-MARKING]; Unit of Use DI Number [type = SINGLE-ITEM]" />
6965       </mapping>
6966     </element>
6967     <element id="DeviceDefinition.udiDeviceIdentifier">
6968       <path value="DeviceDefinition.udiDeviceIdentifier" />
6969       <mustSupport value="true" />
6970     </element>
6971     <element id="DeviceDefinition.udiDeviceIdentifier.deviceIdentifier">
6972       <path value="DeviceDefinition.udiDeviceIdentifier.deviceIdentifier" />
6973       <mapping>
6974         <identity value="devicedefinition-to-eudamed" />
6975         <map value="FLD-UDID-178|UDI-DI code" />
6976       </mapping>
6977       <mapping>
6978         <identity value="devicedefinition-to-gudid" />
6979         <map value="Primary DI Number" />
6980       </mapping>
6981     </element>
6982     <element id="DeviceDefinition.udiDeviceIdentifier.issuer">
6983       <path value="DeviceDefinition.udiDeviceIdentifier.issuer" />
6984       <definition value="Organization accredited by the jurisdictional authority to operate a system for the issuance of UDIs. Main issuers referenced in the US and/or in EU include:
1. GS1 GTIN: urn:oid:1.3.160,
2. HIBCC: urn:oid:2.16.840.1.113883.6.40,
3. ICCBBA Information Standard for Blood and Transplant (ISBT) 128: urn:oid:2.16.840.1.113883.6.18,
4. ICCBBA for other devices: to be found,
5. IFA (Europe Union only): to be found" />
6985       <mapping>
6986         <identity value="devicedefinition-to-eudamed" />
6987         <map value="FLD-UDID-291|Issuing Entity UDI-DI" />
6988       </mapping>
6989       <mapping>
6990         <identity value="devicedefinition-to-gudid" />
6991         <map value="Primary DI Number - Issuing Agency" />
6992       </mapping>
6993     </element>
6994     <element id="DeviceDefinition.udiDeviceIdentifier.jurisdiction">
6995       <path value="DeviceDefinition.udiDeviceIdentifier.jurisdiction" />
6996       <definition value="The jurisdiction to which the deviceIdentifier applies. Known jurisdictions are:
1. US Food & Drug Administration (FDA): urn:oid:2.16.840.1.113883.3.150,
2. Europe Union EUDAMED: https://ec.europa.eu/health/medical-devices-sector_en" />
6997       <mapping>
6998         <identity value="devicedefinition-to-eudamed" />
6999         <map value="https://ec.europa.eu/health/medical-devices-sector_en" />
7000       </mapping>
7001       <mapping>
7002         <identity value="devicedefinition-to-gudid" />
7003         <map value="urn:oid:2.16.840.1.113883.3.150" />
7004       </mapping>
7005     </element>
7006     <element id="DeviceDefinition.udiDeviceIdentifier.marketDistribution">
7007       <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution" />
7008       <mustSupport value="true" />
7009     </element>
7010     <element id="DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.start">
7011       <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.start" />
7012       <mapping>
7013         <identity value="devicedefinition-to-eudamed" />
7014         <map value="FLD-UDID-250|Start date" />
7015       </mapping>
7016       <mapping>
7017         <identity value="devicedefinition-to-gudid" />
7018         <map value="DEVICE RECORD STATUS - DI Record Publish Date" />
7019       </mapping>
7020     </element>
7021     <element id="DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.end">
7022       <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.end" />
7023       <mapping>
7024         <identity value="devicedefinition-to-eudamed" />
7025         <map value="FLD-UDID-251|End date" />
7026       </mapping>
7027       <mapping>
7028         <identity value="devicedefinition-to-gudid" />
7029         <map value="Commercial Distribution End Date" />
7030       </mapping>
7031     </element>
7032     <element id="DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction">
7033       <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction" />
7034       <mapping>
7035         <identity value="devicedefinition-to-eudamed" />
7036         <map value="FLD-UDID-141|Countries were the devices is made available" />
7037       </mapping>
7038       <mapping>
7039         <identity value="devicedefinition-to-gudid" />
7040         <map value="urn:oid:2.16.840.1.113883.3.150" />
7041       </mapping>
7042     </element>
7043     <element id="DeviceDefinition.partNumber">
7044       <path value="DeviceDefinition.partNumber" />
7045       <mustSupport value="true" />
7046       <mapping>
7047         <identity value="devicedefinition-to-eudamed" />
7048         <map value="FLD-UDID-163|Reference / Catalogue Number" />
7049       </mapping>
7050       <mapping>
7051         <identity value="devicedefinition-to-gudid" />
7052         <map value="Catalog Number" />
7053       </mapping>
7054     </element>
7055     <element id="DeviceDefinition.manufacturer">
7056       <path value="DeviceDefinition.manufacturer" />
7057       <mustSupport value="true" />
7058       <mapping>
7059         <identity value="devicedefinition-to-eudamed" />
7060         <map value="FLD-UDID-10|Legal Manufacturer SRN" />
7061       </mapping>
7062       <mapping>
7063         <identity value="devicedefinition-to-gudid" />
7064         <map value="Company Name" />
7065       </mapping>
7066     </element>
7067     <element id="DeviceDefinition.deviceName">
7068       <path value="DeviceDefinition.deviceName" />
7069       <mustSupport value="true" />
7070     </element>
7071     <element id="DeviceDefinition.deviceName.name">
7072       <path value="DeviceDefinition.deviceName.name" />
7073       <mapping>
7074         <identity value="devicedefinition-to-eudamed" />
7075         <map value="FLD-UDID-22|Device Name" />
7076       </mapping>
7077       <mapping>
7078         <identity value="devicedefinition-to-gudid" />
7079         <map value="Brand Name" />
7080       </mapping>
7081     </element>
7082     <element id="DeviceDefinition.deviceName.type">
7083       <path value="DeviceDefinition.deviceName.type" />
7084       <mapping>
7085         <identity value="devicedefinition-to-eudamed" />
7086         <map value="[registered-name]" />
7087       </mapping>
7088       <mapping>
7089         <identity value="devicedefinition-to-gudid" />
7090         <map value="[registered-name]" />
7091       </mapping>
7092     </element>
7093     <element id="DeviceDefinition.modelNumber">
7094       <path value="DeviceDefinition.modelNumber" />
7095       <mustSupport value="true" />
7096       <mapping>
7097         <identity value="devicedefinition-to-eudamed" />
7098         <map value="FLD-UDID-20|Device Model" />
7099       </mapping>
7100       <mapping>
7101         <identity value="devicedefinition-to-gudid" />
7102         <map value="Version or Model" />
7103       </mapping>
7104     </element>
7105     <element id="DeviceDefinition.classification">
7106       <path value="DeviceDefinition.classification" />
7107       <slicing>
7108         <discriminator>
7109           <type value="pattern" />
7110           <path value="type.coding.system" />
7111         </discriminator>
7112         <description value="Slice based on classification.type pattern" />
7113         <rules value="open" />
7114       </slicing>
7115     </element>
7116     <element id="DeviceDefinition.classification:gmdn">
7117       <path value="DeviceDefinition.classification" />
7118       <sliceName value="gmdn" />
7119       <short value="GMDN classification" />
7120       <definition value="Global Medical Device Nomenclature classification" />
7121       <min value="0" />
7122       <max value="*" />
7123     </element>
7124     <element id="DeviceDefinition.classification:gmdn.type.coding.system">
7125       <path value="DeviceDefinition.classification.type.coding.system" />
7126       <min value="1" />
7127       <patternUri value="http://terminology.hl7.org/CodeSystem/GMDN" />
7128       <mapping>
7129         <identity value="devicedefinition-to-gudid" />
7130         <map value="http://terminology.hl7.org/CodeSystem/GMDN" />
7131       </mapping>
7132     </element>
7133     <element id="DeviceDefinition.classification:gmdn.type.coding.code">
7134       <path value="DeviceDefinition.classification.type.coding.code" />
7135       <mapping>
7136         <identity value="devicedefinition-to-gudid" />
7137         <map value="[GMDN code]" />
7138       </mapping>
7139     </element>
7140     <element id="DeviceDefinition.classification:gmdn.type.coding.display">
7141       <path value="DeviceDefinition.classification.type.coding.display" />
7142       <mapping>
7143         <identity value="devicedefinition-to-gudid" />
7144         <map value="GMDN Preferred Term Name" />
7145       </mapping>
7146     </element>
7147     <element id="DeviceDefinition.classification:snomed">
7148       <path value="DeviceDefinition.classification" />
7149       <sliceName value="snomed" />
7150       <short value="SNOMED CT" />
7151       <definition value="Systematized nomenclature of medicine - clinical terms" />
7152       <min value="0" />
7153       <max value="1" />
7154     </element>
7155     <element id="DeviceDefinition.classification:snomed.type.coding.system">
7156       <path value="DeviceDefinition.classification.type.coding.system" />
7157       <min value="1" />
7158       <patternUri value="http://snomed.info/sct" />
7159     </element>
7160     <element id="DeviceDefinition.classification:emdn">
7161       <path value="DeviceDefinition.classification" />
7162       <sliceName value="emdn" />
7163       <short value="EMDN" />
7164       <definition value="European Medical Device Nomenclature" />
7165       <min value="0" />
7166       <max value="1" />
7167     </element>
7168     <element id="DeviceDefinition.classification:emdn.type.coding.system">
7169       <path value="DeviceDefinition.classification.type.coding.system" />
7170       <min value="1" />
7171       <patternUri value="urn:oid:1.2.250.1.213.2.68" />
7172       <mapping>
7173         <identity value="devicedefinition-to-eudamed" />
7174         <map value="urn:oid:1.2.250.1.213.2.68" />
7175       </mapping>
7176     </element>
7177     <element id="DeviceDefinition.classification:emdn.type.coding.code">
7178       <path value="DeviceDefinition.classification.type.coding.code" />
7179       <mapping>
7180         <identity value="devicedefinition-to-eudamed" />
7181         <map value="[EMDN code]" />
7182       </mapping>
7183     </element>
7184     <element id="DeviceDefinition.classification:emdn.type.coding.display">
7185       <path value="DeviceDefinition.classification.type.coding.display" />
7186       <mapping>
7187         <identity value="devicedefinition-to-eudamed" />
7188         <map value="EMDN name" />
7189       </mapping>
7190     </element>
7191     <element id="DeviceDefinition.hasPart.count">
7192       <path value="DeviceDefinition.hasPart.count" />
7193       <mustSupport value="true" />
7194     </element>
7195     <element id="DeviceDefinition.packaging.type">
7196       <path value="DeviceDefinition.packaging.type" />
7197       <mapping>
7198         <identity value="devicedefinition-to-gudid" />
7199         <map value="Package Type" />
7200       </mapping>
7201     </element>
7202     <element id="DeviceDefinition.packaging.count">
7203       <path value="DeviceDefinition.packaging.count" />
7204       <mustSupport value="true" />
7205       <mapping>
7206         <identity value="devicedefinition-to-eudamed" />
7207         <map value="FLD-UDID-121|Quantity of item(s)" />
7208       </mapping>
7209       <mapping>
7210         <identity value="devicedefinition-to-gudid" />
7211         <map value="Quantity per Package" />
7212       </mapping>
7213     </element>
7214     <element id="DeviceDefinition.packaging.udiDeviceIdentifier">
7215       <path value="DeviceDefinition.packaging.udiDeviceIdentifier" />
7216       <type>
7217         <code value="BackboneElement" />
7218       </type>
7219       <mustSupport value="true" />
7220     </element>
7221     <element id="DeviceDefinition.packaging.udiDeviceIdentifier.deviceIdentifier">
7222       <path value="DeviceDefinition.packaging.udiDeviceIdentifier.deviceIdentifier" />
7223       <mapping>
7224         <identity value="devicedefinition-to-eudamed" />
7225         <map value="FLD-UDID-120|Package UDI-DI" />
7226       </mapping>
7227       <mapping>
7228         <identity value="devicedefinition-to-gudid" />
7229         <map value="Package DI Number" />
7230       </mapping>
7231     </element>
7232     <element id="DeviceDefinition.packaging.udiDeviceIdentifier.issuer">
7233       <path value="DeviceDefinition.packaging.udiDeviceIdentifier.issuer" />
7234       <definition value="Organization accredited by the jurisdictional authority to operate a system for the issuance of UDIs. Main issuers referenced in the US and/or in EU include:
1. GS1 GTIN: urn:oid:1.3.160,
2. HIBCC: urn:oid:2.16.840.1.113883.6.40,
3. ICCBBA Information Standard for Blood and Transplant (ISBT) 128: urn:oid:2.16.840.1.113883.6.18,
4. ICCBBA for other devices: to be found,
5. IFA (Europe Union only): to be found" />
7235     </element>
7236     <element id="DeviceDefinition.packaging.udiDeviceIdentifier.jurisdiction">
7237       <path value="DeviceDefinition.packaging.udiDeviceIdentifier.jurisdiction" />
7238       <mapping>
7239         <identity value="devicedefinition-to-gudid" />
7240         <map value="urn:oid:2.16.840.1.113883.3.150" />
7241       </mapping>
7242     </element>
7243     <element id="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.end">
7244       <path value="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.end" />
7245       <mapping>
7246         <identity value="devicedefinition-to-gudid" />
7247         <map value="Package Discontinue Date" />
7248       </mapping>
7249     </element>
7250     <element id="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.subJurisdiction">
7251       <path value="DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.subJurisdiction" />
7252       <mapping>
7253         <identity value="devicedefinition-to-gudid" />
7254         <map value="urn:oid:2.16.840.1.113883.3.150" />
7255       </mapping>
7256     </element>
7257     <element id="DeviceDefinition.safety">
7258       <path value="DeviceDefinition.safety" />
7259       <mustSupport value="true" />
7260       <mapping>
7261         <identity value="devicedefinition-to-eudamed" />
7262         <map value="FLD-UDID-212|Critical Warnings type: {CW025:MR SAFE, CW026:MR CONDITIONAL, CW027:MR UNSAFE, CW023:Consider hazards from magnetic fields, CW024:Do not store near magnets or magnetic devices}" />
7263       </mapping>
7264       <mapping>
7265         <identity value="devicedefinition-to-eudamed" />
7266         <map value="FLD-UDID-156|Containing latex (Boolean)" />
7267       </mapping>
7268       <mapping>
7269         <identity value="devicedefinition-to-gudid" />
7270         <map value="What MRI safety information does the labeling contain?" />
7271       </mapping>
7272       <mapping>
7273         <identity value="devicedefinition-to-gudid" />
7274         <map value="Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)" />
7275       </mapping>
7276       <mapping>
7277         <identity value="devicedefinition-to-gudid" />
7278         <map value="Device labeled as "Not made with natural rubber latex"" />
7279       </mapping>
7280     </element>
7281     <element id="DeviceDefinition.property">
7282       <path value="DeviceDefinition.property" />
7283       <mustSupport value="true" />
7284       <mapping>
7285         <identity value="devicedefinition-to-eudamed" />
7286         <map value="FLD-UDID-16|Risk Class: {Medical Devices: CLASS_I, CLASS_IIa, CLASS_IIb, CLASS_III} {In Vitro Diagnostic Devices: CLASS_A, CLASS_B, CLASS_C, CLASS_D}" />
7287       </mapping>
7288       <mapping>
7289         <identity value="devicedefinition-to-eudamed" />
7290         <map value="FLD-UDID-18|Tissues and cells - Presence of animal tissues or Cells, or their derivates (Boolean)" />
7291       </mapping>
7292       <mapping>
7293         <identity value="devicedefinition-to-eudamed" />
7294         <map value="FLD-UDID-34|Tissues and cells - Presence of cells or substances of microbial origin (Boolean)" />
7295       </mapping>
7296       <mapping>
7297         <identity value="devicedefinition-to-eudamed" />
7298         <map value="FLD-UDID-23|Tissues and cells - presence of human tissues or cells, or their derivates (Boolean)" />
7299       </mapping>
7300       <mapping>
7301         <identity value="devicedefinition-to-eudamed" />
7302         <map value="FLD-UDID-28|Active Device (Boolean)" />
7303       </mapping>
7304       <mapping>
7305         <identity value="devicedefinition-to-eudamed" />
7306         <map value="FLD-UDID-29|Device Intended to administer and/or Remove medicinal product (Boolean)" />
7307       </mapping>
7308       <mapping>
7309         <identity value="devicedefinition-to-eudamed" />
7310         <map value="FLD-UDID-30|Implantable (Boolean)" />
7311       </mapping>
7312       <mapping>
7313         <identity value="devicedefinition-to-eudamed" />
7314         <map value="FLD-UDID-31|Measuring Function (Boolean)" />
7315       </mapping>
7316       <mapping>
7317         <identity value="devicedefinition-to-eudamed" />
7318         <map value="FLD-UDID-32|Reusable Surgical Instruments (Boolean)" />
7319       </mapping>
7320       <mapping>
7321         <identity value="devicedefinition-to-eudamed" />
7322         <map value="FLD-UDID-33|Companion Diagnostic (Boolean)" />
7323       </mapping>
7324       <mapping>
7325         <identity value="devicedefinition-to-eudamed" />
7326         <map value="FLD-UDID-35|Near Patient Testing (Boolean)" />
7327       </mapping>
7328       <mapping>
7329         <identity value="devicedefinition-to-eudamed" />
7330         <map value="FLD-UDID-36|Patient Self Testing (Boolean)" />
7331       </mapping>
7332       <mapping>
7333         <identity value="devicedefinition-to-eudamed" />
7334         <map value="FLD-UDID-155|Presence of a substance which, if used separately, may be considered to be a medicinal product derived from human blood or plasma (Boolean)" />
7335       </mapping>
7336       <mapping>
7337         <identity value="devicedefinition-to-eudamed" />
7338         <map value="FLD-UDID-158|Presence of substance which, if used separately, may be considered to be a medicinal product (Boolean)" />
7339       </mapping>
7340       <mapping>
7341         <identity value="devicedefinition-to-eudamed" />
7342         <map value="FLD-UDID-262|Reagent (Boolean)" />
7343       </mapping>
7344       <mapping>
7345         <identity value="devicedefinition-to-eudamed" />
7346         <map value="FLD-UDID-263|Professional Testing (Boolean)" />
7347       </mapping>
7348       <mapping>
7349         <identity value="devicedefinition-to-eudamed" />
7350         <map value="FLD-UDID-264|Instrument (Boolean)" />
7351       </mapping>
7352       <mapping>
7353         <identity value="devicedefinition-to-eudamed" />
7354         <map value="FLD-UDID-356|Kit (Boolean)" />
7355       </mapping>
7356       <mapping>
7357         <identity value="devicedefinition-to-eudamed" />
7358         <map value="FLD-UDID-12|Device, Procedure pack or System {SYSTEM, PROCEDURE_PACK, DEVICE}" />
7359       </mapping>
7360       <mapping>
7361         <identity value="devicedefinition-to-eudamed" />
7362         <map value="FLD-UDID-167|Labelled as single use (Boolean)" />
7363       </mapping>
7364       <mapping>
7365         <identity value="devicedefinition-to-eudamed" />
7366         <map value="FLD-UDID-169|Device labelled Sterile" />
7367       </mapping>
7368       <mapping>
7369         <identity value="devicedefinition-to-eudamed" />
7370         <map value="FLD-UDID-170|Need for sterilisation before use" />
7371       </mapping>
7372       <mapping>
7373         <identity value="devicedefinition-to-eudamed" />
7374         <map value="FLD-UDID-146|Clinical Sizes {Angle, Diameter, Gauge, Inflation volume, Length, Pressure, Size, Volume, Width, Weight, Heigth, Wavelength, Frequency,...}" />
7375       </mapping>
7376       <mapping>
7377         <identity value="devicedefinition-to-eudamed" />
7378         <map value="Handling Environment Temperature" />
7379       </mapping>
7380       <mapping>
7381         <identity value="devicedefinition-to-gudid" />
7382         <map value="For Single-Use" />
7383       </mapping>
7384       <mapping>
7385         <identity value="devicedefinition-to-gudid" />
7386         <map value="Prescription Use (Rx)" />
7387       </mapping>
7388       <mapping>
7389         <identity value="devicedefinition-to-gudid" />
7390         <map value="Over the Counter (OTC)" />
7391       </mapping>
7392       <mapping>
7393         <identity value="devicedefinition-to-gudid" />
7394         <map value="Kit" />
7395       </mapping>
7396       <mapping>
7397         <identity value="devicedefinition-to-gudid" />
7398         <map value="Combination Product" />
7399       </mapping>
7400       <mapping>
7401         <identity value="devicedefinition-to-gudid" />
7402         <map value="Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)" />
7403       </mapping>
7404       <mapping>
7405         <identity value="devicedefinition-to-gudid" />
7406         <map value="Device Packaged as Sterile" />
7407       </mapping>
7408       <mapping>
7409         <identity value="devicedefinition-to-gudid" />
7410         <map value="Requires Sterilization Prior to Use" />
7411       </mapping>
7412       <mapping>
7413         <identity value="devicedefinition-to-gudid" />
7414         <map value="Storage Environment Temperature" />
7415       </mapping>
7416       <mapping>
7417         <identity value="devicedefinition-to-gudid" />
7418         <map value="Handling Environment Temperature" />
7419       </mapping>
7420       <mapping>
7421         <identity value="devicedefinition-to-gudid" />
7422         <map value="Size - Length" />
7423       </mapping>
7424       <mapping>
7425         <identity value="devicedefinition-to-gudid" />
7426         <map value="Size - Width" />
7427       </mapping>
7428       <mapping>
7429         <identity value="devicedefinition-to-gudid" />
7430         <map value="Size - Heigth" />
7431       </mapping>
7432       <mapping>
7433         <identity value="devicedefinition-to-gudid" />
7434         <map value="Size - Angle" />
7435       </mapping>
7436     </element>
7437     <element id="DeviceDefinition.contact">
7438       <path value="DeviceDefinition.contact" />
7439       <mapping>
7440         <identity value="devicedefinition-to-eudamed" />
7441         <map value="FLD-UDID-354|Contact Details" />
7442       </mapping>
7443       <mapping>
7444         <identity value="devicedefinition-to-gudid" />
7445         <map value="CUSTOMER CONTACT" />
7446       </mapping>
7447     </element>
7448     <element id="DeviceDefinition.productionIdentifierInUDI">
7449       <path value="DeviceDefinition.productionIdentifierInUDI" />
7450       <mapping>
7451         <identity value="devicedefinition-to-gudid" />
7452         <map value="PRODUCTION IDENTIFIER(S) IN UDI" />
7453       </mapping>
7454     </element>
7455     <element id="DeviceDefinition.guideline">
7456       <path value="DeviceDefinition.guideline" />
7457       <mustSupport value="true" />
7458     </element>
7459   </differential>
7460 </StructureDefinition>